Automated external defibrillator systems and methods of use

ABSTRACT

An automated external defibrillator (AED) system includes an AED operations block for controlling operational aspects of the AED system. AED operations block includes pads for attachment to a patient, an electrocardiogram monitoring circuitry for monitoring patient heartbeat, shock generating electronics for generating at least one electrical shock signal to be applied to the patient through the pads, a battery for supplying power to the AED operations block, a power management block for managing power consumption by the shock generating electronics and monitoring a power status of the battery, a memory for storing information regarding the AED system, a user-interface block for providing use instructions and receiving user input, and a controller for regulating the ECG monitoring circuitry, shock generating electronics, and the power management block. The AED system also includes a communications block, also regulated by the controller, for communicating with an external system separate from the AED system.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 15/847,826, filed Dec. 19, 2017, and entitled “AutomaticExternal Defibrillator Device and Methods of Use,” which claims thebenefit of U.S. Provisional Patent Application No. 62/436,208, filedDec. 19, 2016, and entitled, “Automatic External Defibrillator Deviceand Methods of Use”. This application also claims the benefit of U.S.Provisional Patent Application No. 62/947,959, filed Dec. 13, 2019, andentitled, “Automatic External Defibrillator System and Methods of Use.”Each one of these aforementioned applications is incorporated herein byreference in its entirety.

FIELD OF THE DISCLOSURE

Aspects of the present disclosure generally relate to automated externaldefibrillators (AEDs) and, more particularly, to compact AED systems.

BACKGROUND OF THE DISCLOSURE

There are 395,000 Out of Hospital Cardiac Arrests (OHCA) that occur eachyear in the United States. Studies have shown that the use of anAutomatic External Defibrillator (AED) can increase the rate ofsurvivability of OHCA by 40%. However, only 2% of OHCA will occur at alocation at which an AED is available. While there is a big push toincrease dissemination of Public Access Defibrillators (PAD), researchhas also shown that 80% of OHCA happen in the home, where the majorityof people do not have access to an AED.

Additionally, studies have shown that Sudden Cardiac Arrest (SCA)patients have improved outcomes when the length of time between incidentand shock is reduced. When an AED is not readily available at thelocation at which the OHCA occurs, the time from incident to shock isdependent upon the timely arrival of Emergency Medical Services (EMS).The national average for time of EMS arrival is 9 minutes and, duringthese 9 minutes, the chance of patient survival decreases by 7-10% everyminute. Consequently, SCA patients are more likely to survive withfavorable outcomes if the EMS response time is within 8 minutes.

There are three time-sensitive stages of cardiac arrest: 1) electricphase (up to 4 minutes following cardiac arrest, during which the heartis most receptive to electrical shock); 2) circulatory phase(approximately 4 minutes to 10 minutes following cardiac arrest); and 3)metabolic phase (extending beyond approximately 10 minutes followingcardiac arrest). Studies using wearable cardioverter defibrillators haveshown that addressing cardiac arrest during the initial electric phaseresults in a 98% first time cardioversion success rate. As a result,rapid administration of an AED treatment to the SCA patient during theelectrical phase has shown success with survival rates as high as 74%.

Currently, SCA is a leading cause of death among adults over the age of40 in the United States and several other countries. In the U.S. alone,approximately 326,200 people of all ages experience out-of-hospitalnon-traumatic SCA each year, and nine out of ten of these victims die asa result. There are a number of AED solutions for the defibrillation ofthe lethal arrhythmias suffered by SCA patients. While some of thesesolutions attempt to make the AED more portable, they fail to meet theneeds of the user because they are still cumbersome and heavy, thus arenot truly portable devices. For example, the lightest AED currentlyavailable on the market is 2.5 pounds, making carrying an AED on-personunlikely. Other products attempt to assist the bystander by promptingthem in giving quality CPR, although these products still haveshortcomings. Studies show that decreasing the time-to-shock can greatlyincrease the chance of patient survival, such that four out of ten SCApatients survive when bystanders intervene by giving CPR and using anAED before the arrival of EMS personnel. Unfortunately, only one-third(32%) of SCA patients receive bystander CPR, and bystanders treat only2% of those with AEDs. If bystanders had a readily available AED thatcould also shorten the time to EMS notification, analysis of cardiacrhythm, and delivery of shock, potentially 100,000 people per year couldbe saved in the U.S. alone.

One approach to increasing the chance of survival for SCA sufferers isto make AEDs more readily available and accessible for more people.However, the AEDs currently available on the market tend to be heavy,not portable, expensive, and intimidating to use for people withoutmedical training. For example, US Pat. Pub. No. US 2018/0169426,entitled “Automatic External Defibrillator Device and Methods of Use,”which disclosure is incorporated herein in its entirety by reference,provides a possible solution to overcome the availability andaccessibility problem by providing a compact AED device suitable forportability.

Aspects of the present disclosure provide techniques and structures thatimprove the performance of AEDs suitable for high portabilityapplications.

SUMMARY OF THE DISCLOSURE

In accordance with the embodiments provided herein, there is provided anautomated external defibrillator (AED) system including an AEDoperations block for controlling operational aspects of the AED system.AED operations block includes pads for attachment to a patient, anelectrocardiogram monitoring circuitry for monitoring patient heartbeat,shock generating electronics for generating at least one electricalshock signal to be applied to the patient through the pads, a batteryfor supplying power to the AED operations block, a power managementblock for managing power consumption by the shock generating electronicsand monitoring a power status of the battery, a memory for storinginformation regarding the AED system, a user-interface block forproviding use instructions and receiving user input, and a controllerfor regulating the ECG monitoring circuitry, shock generatingelectronics, and the power management block. The AED system alsoincludes a communications block, also regulated by the controller, forcommunicating with an external system separate from the AED system.

In accordance with another embodiment, a method of transmitting datafrom an automated external defibrillator (AED) system to emergencymedical services is disclosed. The method includes, at the AED system,gathering at least one of a location of the AED system and patientinformation, and electronically transmitting the at least one of thelocation of the AED system and patient information from the AED systemto emergency medical services.

In an embodiment, the patient information includes at least one ofcardiac rhythm and vital signs. In another embodiment, the AED systemincludes an AED operations block configured for operating the AEDsystem, and the AED system further includes a communications blockconfigured for receiving information from and transmitting informationto emergency medical services.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an automated external defibrillator (AED) module, inaccordance with an embodiment.

FIG. 2 illustrates an internal configuration of a control panel withinan AED module, in accordance with an embodiment.

FIG. 3 illustrates a configuration of the internal components of an AEDcontrol module in certain embodiments.

FIG. 4 illustrates an exploded view of an AED module in certainembodiments.

FIG. 5 illustrates a configuration of an AED module with control panelconnected to a photo-plethysmography (PPG) monitor, cardiac pads, and asmartphone/mobile device in certain embodiments.

FIG. 6A illustrates an electronic configuration of an AED module incertain embodiments.

FIG. 6B illustrates a configuration of a PPG monitor in certainembodiments.

FIG. 7 illustrates a flowchart showing interaction of the user withembodiments of an application, control module, smartphone, and emergencyservices.

FIG. 8 illustrates a flowchart showing interaction of the user withembodiments of an application, control module, smartphone, and emergencyservices.

FIG. 9 illustrates a flowchart showing interaction of the user withembodiments of an application, control module, smartphone, and emergencyservices.

FIG. 10 illustrates a simplified AED Biphasic Truncated Exponential(BTE) power stage in certain embodiments.

FIG. 11 illustrates a graph showing adjustments made to the shockwaveform based on body impedance, in accordance with an embodiment.

FIG. 12 illustrates an alternative boost power stage in certainembodiments.

FIG. 13. A relational diagram showing the communications between an AEDoperations control module and other firmware within the AED module, inaccordance with an embodiment.

FIG. 14 illustrates a flowchart showing the firmware process for AEDstandby mode, in accordance with an embodiment.

FIGS. 15-16 illustrates a flowchart showing the firmware process foradministration of a shock protocol, in accordance with an embodiment.

FIG. 17 illustrates a flowchart showing the firmware process formonitoring a SCA patient using the AED module, in accordance with anembodiment.

FIGS. 18-19 illustrates a flowchart showing the firmware process formanaging a shock protocol and generating an electric shock, inaccordance with an embodiment.

FIG. 20 illustrates a configuration of a bracket on which the AED moduleis mounted, in accordance with an embodiment.

FIGS. 21-23 illustrate iso, top, and side views of an exemplary AEDmodule, in accordance with an embodiment.

FIG. 24 illustrates an exemplary electronics architecture of an AEDmodule, in accordance with an embodiment.

FIG. 25 illustrates a block diagram of an exemplary AED, including anAED operations block and a communications block, in accordance with anembodiment.

FIG. 26 shows a block diagram of communications interconnections enabledby the communications module of the exemplary AED, in accordance with anembodiment.

FIG. 27 shows a flow diagram illustrating an exemplary process flow forusing the exemplary AED to treat a person experiencing SCA, inaccordance with an embodiment. The interactions between actions taken bythe user of the exemplary AED, the resulting actions by a controllerwithin the exemplary AED, and the displayed prompts at the userinterface as a result of the user and controller actions are shown inthe flow diagram.

FIG. 28 shows a flow diagram illustrating an exemplary process flow forperforming a status check and error remediation for an exemplary AED, inaccordance with an embodiment.

FIG. 29 shows a flow diagram illustrating an exemplary process forperforming a status check and error remediation for an exemplary AEDusing an auxiliary application, in accordance with an embodiment.

FIG. 30 shows a flow diagram illustrating an exemplary process flow forlocating nearby AEDs using an auxiliary application, in accordance withan embodiment.

FIG. 31 shows a block diagram of the exemplary AED of FIG. 25 with abracket compatible with the exemplary AED.

DETAILED DESCRIPTION

The embodiments described in the present disclosure seeks to solve theproblems described in the Background by providing an AED device withimproved features over the existing products. For instance, as correctpositioning of the cardiac pads has been correlated with improvedsurvival rates, it would be desirable for an AED to provide anindication of whether the cardiac pads have been placed correctly on theSCA patient. Also, currently available AED devices do not provide anoption to connect to a mobile device that can contact EMS to initiate afaster response by emergency medical personnel and, subsequently,earlier hospital arrival. Moreover, currently available AED devices donot provide a smartphone/mobile device application for the notificationand treatment of suspected cardiac arrest instances to EMS.

It would be desirable to have a device that can significantly improvethe outcome of an SCA patient by providing, even to a non-medicallytrained person, the ability to detect a shockable cardiac rhythm andapply a therapeutic electrical shock to the SCA patient. Therefore,there currently exists a need in the industry for a truly portable AEDand associated methodology that closes the gap between time of incident,application of CPR, and delivery of shock. If more AEDs can be madeavailable to more people, with portability, lower cost, and enhancedease of use, then more lives can be saved in the event of an SCAoccurring outside of a hospital setting. That is, like an EpiPen™injector is prescribed for and carried by those diagnosed withpotentially life-threatening allergies, a portable AED can be anecessary and routine item prescribed to those diagnosed as being atrisk for SCA. A portable, affordable, and user-friendly AED with safeand simple application protocol is desired for such wide-spreadproliferation of AEDs in the consumer market. Additionally, secure andstreamlined connections to emergency personnel, external data sources,and peripheral devices would also be desirable.

To address the aforementioned shortcomings of the existing art, certainembodiments of the system described herein provides a compact AutomaticExternal Defibrillator and smartphone device application that assists inthe notification of suspected cardiac arrest to Emergency MedicalServices and assists in guiding bystander CPR and arrhythmia conversion.

Certain embodiments described herein further include a smartphone devicewith associated application software. Alternatively, the smartphonedevice or a control module allows for cardiac monitoring, vital signsmonitoring, defibrillation, and telecommunications that to enableGPS-specific contact with emergency services.

An exemplary embodiment of the AED includes: (1) a defibrillatorincluding a battery to charge a capacitor to store and deliver anelectric shock; (2) a communication module to connect the defibrillatorto a smartphone/mobile device via wired or wireless connection; (3)cardiac pads with electrodes to detect and monitor chest wallcompression depth, compression rate, and chest wall impedance, and heartrhythm; and (4) a smartphone or mobile device application to analyzeinformation received from the cardiac pads and recommend appropriatetherapy, the application also having the ability to contact EMS via thesmartphone/mobile device with GPS, Wi-Fi and/or cellular capabilities.In certain embodiments, these components are connected as follows: asmartphone with application is connected to the defibrillator via eithera wired or wireless connection, such as Bluetooth or Wi-Fi, then atleast two electrodes with wires ending in cardiac pads connect from thebattery/capacitor pack to the patient's chest.

Certain embodiments include one or more of the following: (1) thesmartphone application installer resides in the battery pack and isautomatically uploaded to any device connected thereto; (2) deviceconnects to a smartphone or mobile device via a wired or wirelessconnection (e.g., Bluetooth, Wi-Fi), or through a microphone; (3) thecharge for the defibrillating shock is generated from a replaceabledevice-centric source (e.g., battery) or from the internal battery ofthe smartphone; (4) device includes a control module, at least onecapacitor and application to detect and deliver any range of electricalshock; (5) the system components and application detect the impedance ofthe victim's chest wall and cardiac pad placement; (6) given impedanceinformation, the system and application automatically recommends orconfigures an electrical charge for the given SCA patient (e.g., childor adult); (7) the cardiac pads can be placed anywhere on the body ofthe SCA patient; (8) the cardiac pads detect the force of the CPRcompressions on the SCA patient using, for example, a pressure sensor,impedance detector and/or accelerometer; (9) the smartphone interfaceswith multiple other medical devices via wired or wireless connections(e.g., Bluetooth or Wi-Fi) or microphone; (10) the application monitorsa variety of sources of data to: A) refine CPR-related guidance and/orB) bundle the data to be accessible by first responders; (11) thesmartphone interfaces with other medical devices and detects andmonitors vital signs on the SCA patient including, but not limited to,blood pressure, heart rate, oxygen saturation, temperature, respiratoryrate, capnography, and electrical cardiac activity; (12) the device hastwo or more electrodes (e.g., cardiac pads) that connect to the patient;(13) the smartphone/device/electrode combination provide a 12-leadelectrocardiography (ECG) output; (14) the AED is brand agnostic withrespect to the smartphone or operating system; (15) the smartphone canbe paired via wireless communications or connect via wire to multiplemedical devices simultaneously; (16) the AED can be connected/paired tomultiple smartphones simultaneously and, if paired, each of thesedevices can have control over the AED; (17) the device allows the userto perform cardiac pacing/synchronized shock from the smartphone device,if the user has the appropriate knowledge; (18) the smartphone providesa live video, voice, data or any combination of these feeds to anothermedical facility; (19) the smartphone communicates with EMS via anautomated voice annunciation via cellular network, video, SMS or anyother modality by which EMS is able to receive information; (20)information given to EMS includes, but is not limited to, current vitalsigns, CPR results, detectable cardiac rhythm, number of shocks given,and GPS coordinates/geolocation of events in progress; (21) suchinformation is generated on a periodic basis and transmitted to incomingEMS, or generated upon request by EMS via the application; (22) EMS isable to access the application on a paired mobile device, facilitatingdevice location and data requests therefrom; (23) the application allowsthe control module to be paired with the information system used by EMS,thus allowing the remote administration of cardiac shock (e.g., if achild is using the device for an adult); (24) the device and softwareapplication communicates with cameras of related devices including, forexample, smartphone cameras, Google Glass, or similar products to allowfor direct visualization and display of events and instructions inprogress; (25) the device and software application guides a user forproper cardiac pad placement; (26) the device and software applicationsuggest confirmation of no pulse if the onboard photo-plethysmography(PPG) sensor does not detect a pulse; (27) the device provides guidanceusing industry standard for timing of delivery of shock and CPR; and(28) device automatically contacts EMS if no call to emergency servicesis manually initiated after delivery of first shock.

Certain embodiments differ from other currently available devices andsolutions because the various embodiments described herein: (1) providedefibrillation of a cardiac arrest victim with an empowered smartphone;(2) use batteries that can be purchased off-the-shelf; (3) includespecialized capacitors and circuitry that generate a therapeutic chargefrom the off-the-shelf battery; (4) continuously analyze the cardiacrhythm during CPR; (5) include sensors in the cardiac pads to detectimpedance of the chest wall and ensure proper pad connection; (6)include additional sensors in the cardiac pad to monitor compressionforce, rate and depth of CPR; (7) by using the sensors to monitor vitalsigns, ensure that a cardiac shock is not given at an undesired time;and (8) via the sensors inside the cardiac pad, communicate informationto the software system regarding size of chest wall which then allowsfor recommendation of a therapeutic shock that is correlated with thesize of victim and their individual anatomy, e.g., child or adult.

Similarly, the associated method described herein differs from existingmethods in that: (1) the smartphone software application gives theability to call emergency services (such as 911 in the United States)and assist the bystander in providing effective CPR; (2) the smartphonedevice software application is able to upload and record data of theresuscitation efforts such as, but not limited to, vital signs, cardiacrhythm, quality of CPR, and outcome of electric shock. Certainembodiments also transmit data to another mobile device in real-time, orafter the fact.

Certain embodiments differ structurally from other known devices orsolutions in that: (1) the device runs off of readily commerciallyavailable consumer batteries; (2) the device connects to a mobile deviceand is small enough for everyday portability; and (3) includes cardiacpads that can detect force, rate, and depth of compression along withimpedance of chest wall.

Furthermore, the processes associated with certain embodiments differfrom known processes and solutions in that: (1) the device includes asmartphone device software application initiate communications with EMS;(2) the software application guides a bystander through quality CPRusing the data obtained from the cardiac pads, such as compressiondepth, compression rate, and placement of hands; (3) the device uses thedata to prompt the user if the cardiac pads need to be checked orre-applied or if the CPR technique needs to be modified; (4) softwareapplication detects the cardiac rhythm during active chest compression;(5) the software application analyzes cardiac rhythm and provideselectric shock for appropriate cardiac arrhythmias; and (6) the userwill be prompted to stop CPR upon return of spontaneous circulation(ROSC).

Among other things, it is an object of certain embodiments to provide anautomated external defibrillator and smartphone device application thatassist in the notification of suspected cardiac arrest to EMS and inguiding bystander CPR and arrhythmia conversion to overcome the problemsor deficiencies associated with prior solutions.

It is still further an objective of certain embodiments to create aautomated external defibrillator device that is cost effective, thusincreasing the public's access to AEDs and thereby saving lives.

Further still, it is an objective of certain embodiments to provide adevice that is smaller and more lightweight than other solutions,thereby enabling the device to be easily portable. Certain embodimentshave a weight of less than one pound. By making it more portable itincreases accessibility, thus the product will be utilized morefrequently, ultimately saving more lives.

Further still, it is an objective of certain embodiments to create adevice that is able to help bystanders in a high stress situation toprovide proper help in an efficient manner.

Certain embodiments are related to automated external defibrillator andsmartphone device software application that assist in the notificationof suspected cardiac arrest to EMS and assist in guiding bystander CPRand cardiac arrhythmia conversion.

Certain embodiments include: a smartphone/mobile device, externalbattery pack/specialized capacitors, at least two cardiac pads andsensors with associated wires. In an embodiment, these components areconnected as follows: mobile device is connected via hardwire, Bluetoothor Wi-Fi to a case that holds the battery, specialized capacitors, andcircuitry. The case also holds at least two cardiac pads with sensorsconnected via wire, that are in turn connected to the patient. In anexemplary embodiment, the case protects the user from the risk ofelectrical shock, and protects the internal electronics fromelectrostatic discharge (ESD), which can cause the electronics to failor malfunction in an unsafe way. Suitable materials for the caseincludes, for example, a variety of plastics and other insulatingmaterials.

Connecting the various components to the mobile device is done via wireto a connection port on the mobile device or via a wireless mechanismsuch as Bluetooth or Wi-Fi. The mobile device includes software forreceiving input via wire or wireless connection from the case and othervital sign attachments. The software can recommend initiating a call toemergency services (e.g., 911). The automated connection via cellularnetwork, video or SMS to EMS will be able to disclose the location ofthe AED being operated. The mobile device and software can automaticallysend the patient's information including, but not limited to, vitalsigns and cardiac rhythm to the EMS dispatch and/or regional medicalcenter. The automated system can guide the user regarding correct depthand rate of compression and be able to advise cardiac shock. The caseholds a portable battery, capacitors, and circuitry to generate andstore at least one electrical charge to produce a therapeutic charge tocardiovert a patient in cardiac arrhythmia with the goal of return ofspontaneous circulation (ROSC). The cardiac pads are connected to the tothe case via hardwires. The cardiac pads are able to detect cardiacrhythm when active CPR is taking place. As an example, the cardiac padshave sensors embedded that will be able to detect rate and depth ofcompressions of the bystander providing CPR. The sensors in the cardiacpads send information back to the mobile device application for analysisof shockable versus non-shockable cardiac rhythm. The cardiac pads areused to deliver the therapeutic shock to the heart. The cardiac padsdetect impedance of the chest to allow the application to calculate thecorrect therapeutic electric shock dosage and also ensure the cardiacpads have the proper connection on the patient to increase the bestchance of cardioverting.

In certain embodiments, the method includes: identifying a person, whois the victim of a suspected cardiac arrest; deploying a portableautomatic external defibrillator device; connecting the portabledefibrillator device to a mobile using a wired or wireless connection;automatically initiating the software to prompt the user to call to EMSby screen button prompt; selecting an option on the screen of the mobiledevice to initiate a call to EMS; and advising EMS of the AED's currentlocation using the mobile device's internal GPS system and request thathelp be sent once connected. In certain embodiments, a user openscardiac pads and places them on the victim's chest in either theanterior/posterior placement or the anterior lateral placement describedon a packing diagram provided on the case of the AED. As soon as thecardiac pads are placed on the victim's chest, the system attempts todetect and analyze the cardiac rhythm of the victim. Concurrently, thesoftware gives voice prompts and a visual display of how to perform CPRto the user. The software also recommends hand placement, compressiondepth, and compression rate for effective quality CPR, in accordancewith American Heart Association guidelines. As soon as a shockablerhythm is identified, the system will prompt via voice and video displayto halt the CPR to initiate a shock to the victim. Once shock isdelivered, the system will prompt the user to resume the proper steps ofCPR. The device can also display the patient's vital signs on a screenduring the time the device is deployed. The vital signs and cardiacrhythm can also be seen by other mobile devices and/or the emergencyservice dispatch or regional medical center. If at any time the sensorson the cardiac pads detect that CPR is not given at the appropriate rateor compression depth recommended by American Heart Association (AHA)guidelines (see, for example, “AED Implementation”(http://cpr.heart.org/AHAECC/CPRAndECC/Programs/AEDImplementation/UCM_473198_AED-Implementation.jsp,accessed 18 Dec. 2017)), the software prompts the user by voice andvideo image to adjust accordingly. The sensors also prompt the user ifimpedance is too high and recommend checking and/or reattaching thecardiac pads as necessary. Data regarding the entire event can bemonitored and saved to another device or to the active device forreal-time or subsequent comparative analysis.

Certain embodiments relate to a device, proprietary software andmethodology associated with the device, including a portabledefibrillator that works with a smartphone and software. When connectedto a patient in cardiac arrest, via two or more electrodes and batterypack/specialized capacitor, the device calls Emergency Medical Servicesproviding a location. It will record patient information such as cardiacrhythm and vital signs that can then be transmitted to an approvedfacility for evaluation by medical providers. The device is also able toanalyze cardiac rhythms, suggests administering one or more shocks tothe patient in appropriate cardiac arrhythmia, and instructs bystanderson proper CPR. The portable defibrillator device and software can alertany other personnel with the app downloaded in a nearby location forassistance. This device can be used for any person that is believed tobe in cardiac arrest by bystanders. The components of certainembodiments include an application for smartphone, a device that isconnected to the smartphone and activates software, the device includestwo or more electrodes with cardiac pads for connection to a person'schest and to a battery pack and capacitor to provide electric shocks. Incertain embodiments, the configuration includes: a smartphone which isconnected by wire to battery pack and capacitor which are connected toelectrodes that are connected to cardiac pads that are placed on thechest of the patient.

With respect to certain embodiments of the device AED module, it shouldbe further noted that once the device has been applied to patient andplugged into the smartphone it will activate the software that willtransmit location, vital signs, and cardiac rhythm to emergencyservices, it will also analyze placement of the cardiac pads to ensureproper rhythm analysis and proper CPR via depth, rate and impedance. Thedevice will recommend administering electric shock to appropriate andsusceptible cardiac arrhythmias. If the device is used properly andthere is a shockable rhythm the goal is the return of spontaneouscirculation (ROSC), activation of emergency medical services andrecording and transmission of data that occurred during event. Withrespect to the associated method, in certain embodiments, the methodincludes: identifying a patient that may have cardiac arrest; placing adevice and communicatively coupling the device to a smartphone;accessing a smartphone application; following instructions from deviceand deliver shock if recommended or provide CPR if recommended and waitfor emergency services to arrive. Ultimately, at the conclusion of thesesteps the device should notify emergency services if cell or Wi-Fisignal allows, provide instructions for CPR or recommend and delivercardiac shock, record vital signs and cardiac rhythm, with theall-encompassing goal of helping bystanders provide emergent andadequate care in a life-threatening situation. A portable AED will leadto improved patient outcomes and more lives being saved.

Referring to the figures, FIG. 1 shows an automated externaldefibrillator (AED) module 10, in accordance with an embodiment. As seenin FIG. 1, AED module 10 includes a connector 11, an electronics module12, at least two electro-conductive cardiac pads 13, and electricalconductors such as wiring 14 connecting cardiac pads 13 with electronicsmodule 12. Cardiac pads 13 includes sensors (not shown) for monitoring,for example, cardiac rhythm and body impedance of the SCA patient towhom cardiac pads 13 are connected. The sensors in cardiac pads 13 alsoindicates whether cardiac pads 13 are properly placed on the SCApatient, and can indicate to electronics module 12 if one or both ofcardiac pads 13 are disconnected from the SCA patient. Furthermore,sensors in cardiac pads 13 can also include additional capabilities,such as detection of force, rate, and depth of compression, to helpmonitor any cardiopulmonary resuscitation (CPR) performed on the SCApatient. Connector 11 is attached to electronics module 12 via a wire 15in the embodiment shown in FIG. 1. Alternatively, the connection betweenthe mobile device and electronics module 12 is established wirelesslythrough, for instance, Bluetooth or Wi-Fi. Connector 11 is attached viaa receptacle 16 to a mobile device 24.

While mobile device 24 in FIG. 1 is shown as a smartphone, it may beanother suitable portable device, such as a cellphone, a tablet, a smartwatch, electronic reader, laptop, or the like. A suitable mobile devicehas the capability to receive input via, for example, wired or wirelessconnections such as Bluetooth, audio, keyboard, mouse, trackpad, ortouch-screen. Additionally, the mobile device produces an output, suchas vibration, camera light, video display Bluetooth, Wi-Fi, or audio.Internal components of a suitable device include, for example, amicroprocessor, a battery, GPS, Wi-Fi and/or Bluetooth, an operatingsystem, software readable media, and storage. When mobile device 24 isconnected with AED module 10, a specialized application software,including features such cardiac rhythm recognition, patient monitoring,impedance measurement, and external communication options, is downloadedand installed on mobile device 24 such that it is able to communicatewith AED module 10.

AED module 10 connects to receptacle 16 of mobile device 24 viaconnector 11, in the embodiment shown in FIG. 1. Certain embodimentsinclude standard connection mechanisms known to those skilled in theart, such as but not limited to micro USB, Lightning connector, andUSB-C, 30-pin, Thunderbolt, audio, or even simultaneous connections withmultiple inputs of mobile device 24. Alternatively, AED module 10connects to mobile device 24 wirelessly (as indicated by symbol 25) viaa mechanism such as Bluetooth, Wi-Fi, or audio. Connector 11 receivesand sends signals from and to electronics module 12, such ascommunications related to, for instance, activation of the specializedsoftware application, the cardiac rhythm analysis, and delivery of atherapeutic shock.

In certain embodiments, AED module 10 automatically activates thespecialized software application installed on mobile device whenconnector 11 is connected to mobile device 24 via receptacle 16. Forinstance, the installed software on mobile device 24 analyzes thecardiac rhythm from cardiac pads 13 that is processed/filtered inelectronics module 12. Alternatively, electronics module 12 performs theanalysis of data received from cardiac pads 13 and displays the analysisresults on mobile device 24. Electronics module 12 generates and storesan electrical charge for at least one electrical shock. If electronicsmodule 12 or the installed software in mobile device 24 deems thepatient is currently undergoing cardiac arrest and can be treated withdefibrillation, a control circuitry (not shown) in electronics module 12sends the generated electrical charge to the SCA patient via cardiacpads 13. Alternatively, shock will be delivered when the user approvesthe shock delivery through the specialized software installed on mobiledevice 24.

In an embodiment, each of cardiac pads 13 is configured to accommodateelectrical charge in the form of a biphasic waveform, as currentlyrecommended by Advanced Cardiovascular Life Support (ACLS) and AmericanHeart Association (AHA) standards. Cardiac pads 13 can be placed in thestandard anterior/lateral position, or can be placed into theanterior/posterior position, among others.

In an embodiment, electronics module 12 itself or the specializedsoftware on the mobile device will analyze the electrocardiography (ECG)signals received via the sensors in cardiac pads 13. The analysisdetermines, for example, whether the cardiac rhythm measured from theSCA patient is indeed a shockable rhythm, in accordance with industrystandards. Industry standard shockable rhythms include, for example,ventricular fibrillation (VF) having an average waveform amplitudegreater than 0.2 mV, fine ventricular fibrillation (FVF) having anamplitude between 0.1 mV and 0.2 mV, and ventricular tachycardia (VT) ofsingle morphology (monomorphic VT) or several morphologies (polymorphicVT) (see, for example, “AED Algorithm Application Note,” Philips, 2008(http://laerdalcdn.blob.core.windows.net/downloads/f2374/AED_algorithm_appiication_note.pdf accessed 10 Dec. 2017).

When analysis by electronics module 12 or the software installed onmobile device 24 determines that the cardiac rhythm detected is ashockable rhythm, data regarding body impedance is used to calculate andadjust the appropriate shock waveform to be delivered via cardiac pads13 to the SCA patient. For instance, the energy output from electronicsmodule 12 is adjusted, according to the body impedance, to produce awaveform according to the accepted standard biphasic pattern used inmodern defibrillators. In certain embodiments, this voltage waveform isgenerally between 120-200 Joules in total energy.

In certain embodiments, the analysis performed by electronics module 12or software provides an optional mode in which rhythms requiring anelectrical shock at a smaller/different electrical output can beidentified. An example for such a rhythm is supraventricular tachycardia(SVT), which requires therapeutic cardioversion or bradycardia withexternal electrical cardiac pacing. In an embodiment, electronics module12 or software on mobile device 24 is able to distinguish the need for asynchronized shock to be delivered on the QRS waves of an ECG reading.Examples of these rhythms would be supraventricular tachycardia (SVT),stable ventricular tachycardia, symptomatic atrial fibrillation andothers.

In certain embodiments, for further data input for the shockabilityanalysis, additional electrodes can be placed in the industry standardpositions to obtain, for instance, a 12-lead ECG reading. With thisoption, the 12-lead ECG data allows better analytics of the SCApatient's condition, such as the identification of a ST elevationmyocardial infarction (STEMI). For instance, diagnostic ST elevation inthe absence of left ventricular (LV) hypertrophy or left bundle-branchblock (LBBB) is defined by the European Society ofCardiology/ACCF/AHA/World Heart Federation Task Force for the UniversalDefinition of Myocardial Infarction as new ST elevation at the J pointof an ECG reading in at least 2 contiguous leads of ≥2 mm (0.2 mV) inmen or ≥1.5 mm (0.15 mV) in women in leads V2-V3 and/or of ≥1 mm (0.1mV) in other contiguous chest leads or the limb leads. If such acondition is identified by electronics module 12 or the softwareinstalled on mobile device 24, AED module 10 notifies EMS, in anembodiment, thus potentially shortening the time to cardiaccatheterization that is needed for treatment of the condition.

In certain embodiments, the specialized software for mobile device 24 ismade available on a software application marketplace (e.g., the AppleApp Store), a specific website on the Internet, or be uploaded manually.Alternatively, a software installer is stored on electronics module 12such that, when a mobile device 24 is connected, the specializedsoftware is automatically downloaded and installed on mobile device 24.As mentioned above, the application may be configured for access by EMSsuch that EMS personnel are able to obtain device location and patientdata, such as analytics of the SCA patient's condition described above.Further, electronics module 12 may also be paired with the informationsystem used by EMS, thus allowing remote access and control of the AED,such as remote administration of cardiac shock and remote adjustments ofthe shock parameters. As a safety proecaution, the specialized softwaremay require authorization to access specific access to the AED. Forinstance, before a particular user is allowed to access the remoteadministration features of the AED, the specialized software may requiremanual (e.g., passcode entry) or biometric (e.g., facial recognition,pupil recognition, or fingerprint recognition) authentication of thatparticular user. Alternatively, the AED may be configured forcompatibility with a separate specialized software specifically forauthorized personnel for accessing medically-crucial features of theAED, such as remote shock parameter adjustment and remote shockadministration. Such specialized software may allow, for example,Bluetooth, cellular, or Wi-Fi access (e.g., via signal 25) toelectronics module 12 of AED module 10.

In certain embodiments, the original equipment manufacturer will preloadthe specialized software on electronics module 12. In certainembodiments, the battery in mobile device 24 can be used to providepower to AED module 10.

Referring to FIG. 2, certain embodiments of the internal configurationof an AED module or an electronics module 12 is shown. In certainembodiments, a battery 17 is a 9-volt battery and, in certainembodiments, can include another off-the-shelf, household batteryincluding, but not limited to, NiMH, NiCd, lithium ion, alkaline,silver-oxide, or silver zinc batteries, singularly or in a combinationthereof.

In certain embodiments, electronics module 12 also includes a series ofcapacitors 18 to generate and store a charge for at least one electricaldefibrillation. In certain embodiments, electronics module 12 alsoincludes a boosting element 19 for amplifying and filtering the signalreceived from the cardiac pads. The signal from the cardiac pads are tobe received via wires 14, amplified and filtered at boosting element 19,and sent from a microprocessor 20 to the software on the mobile deviceto be analyzed. Filtering at boosting element 19 reduceselectromyography (EMG) noise and/or electromagnetic interference (EMI)in the received signal. In an embodiment, boosting element 19 allowsanalysis of the cardiac rhythm while active chest compression (i.e.,CPR) is being administered on the SCA patient. In certain embodiments,microprocessor 20 stores downloaded software from the manufacturer to beuploaded to mobile device 24, in the event the software is not alreadyinstalled on the device.

Electronics module 12 also receives from and transmits to mobile device24 any information via wireless arrangements, such as Bluetooth andWi-Fi using a transmitter 21. In certain embodiments, a port 22 isprovided on electronics module 12 to accept additional electrodes, suchas vital sign devices 23 including, but not limited to, capnography,blood pressure, pulse oximetry, and glucose monitors, smart watches, andGoogle Glass. Software applications equivalent to vital sign devices 23could also be installed on electronics module 12 or mobile device 24using wireless connections, such as Bluetooth, Wi-Fi, or audio, or awired connection.

In certain embodiments, a portable AED module 30 as shown in FIG. 3 isconnected to mobile device 24 via wire 15. Components of AED module 30are placed in or on a housing 31. Certain embodiments include aplurality of indicators 32 that visually show a user the steps forresuscitating a person affected with a cardiac episode. Still referringto FIG. 3, in one example, the indicators include, for example, a HeartAnalysis indicator 32 a, a Place AED/CPR Pad indicator 32 b, a PerformCPR indicator 32 c, a Clear indicator 32 d, a Warning Shock indicator 32e, and a Remove Pads indicator 32 f. Indicators 32 are mounted on anupper cover 41, in an embodiment. It will be appreciated by thoseskilled in the art that the indicators found on an AED module is notlimited to these indicator types, and may include greater than or fewerthan these indicator types.

In certain embodiments, indicators 32 are illuminated to allow a user tovisually verify the steps for performing defibrillation/CPR on a SCApatient. For example, indicators 32 are translucent, and illuminated bylights 38 a found on an indicator board 39, as shown in FIG. 4. Incertain embodiments, a display 34 provides further information. Forexample, a display 34 may be an LCD, VFD, OLED, analog, or other displayto provide information. In certain embodiments, display 34 provides userfeedback, status information, or other information relevant to theprocess of defibrillation or CPR. In certain embodiments, display 34provides heart rate information. In certain embodiments, display 34forms a part of indicator board 39.

Again referring to FIG. 3, in certain embodiments, an interface 33includes speakers that transmit audio cues for using the AED and/oradministering CPR. In certain embodiments, a user listens to the audiocues from interface 33 and follows the instructions of the audio cues.The speakers can transmit other information including, but not limitedto, GPS location, real-time conversation with EMS personnel,instructions for use, among others. In certain embodiments, interface 33further includes a battery life indicator.

Still referring to FIGS. 3 and 4, certain embodiments of portable AEDmodule 30 includes a housing bezel 40. Housing bezel 40 is translucentas to allow light from lights 38 b to pass through. Lights 38 b aremounted on an AED power board 43 and illuminate an area 35 throughhousing bezel 40 to provide further visual information to assist a userwhile in the process of performing defibrillation and/or CPR.Illumination can occur outside of area 35 as well. It will beappreciated that lights 38 a and 38 b can be one or more colors as toprovide color-specific information provided by any number of lightsources, such as light emitting diodes (LEDs), incandescent lighting, orfluorescent lighting.

Referring to FIG. 3, in certain embodiments, a AED power board 43includes a bulk charge storage array 44 as to hold an electrical charge.In certain embodiments, battery 17 connected with AED power board 43provides AED module 30 the charge necessary for defibrillation.Alternatively, other power sources, such as the battery within mobiledevice 24 can be used. In certain embodiments, an insulation 45 providesisolation of circuitry between indicator board 39 and AED power board43. Additionally, a back cover 42 encloses a portion of housing 31. Incertain embodiments, back cover 42 may be removable as to allow a userto replace battery 17.

Referring to FIGS. 3 and 5, certain embodiments of AED module 30 isfurther connected to other components. For example, AED module 30 isconnectable via wires 15, 36, 37 to a mobile device 24,photoplethysmography (PPG) monitor 46, and a plurality of pads 47. Forexample, PPG monitor 46 attaches to an earlobe or finger to detect,vital signs such as blood flow, heart rate, a viable heart rhythm, andblood oxygen saturation (O₂%). In certain embodiments, PPG monitor 46detecting no pulse triggers AED module 30 to direct the user to startadministration of CPR.

Pads 47 include, for example, a CPR coaching pad 48 in addition tocardiac pads 13. In certain embodiments, CPR coaching pad 48 includes oris connected with sensors such as accelerometer, pressure sensor,impedance sensor, and optionally to outputs such as speakers, lightindicators, and others, as shown in FIG. 6A. An accelerometer measuresthe movement of the pad, and a pressure sensor measures the active forceand release of CPR compressions. Thus, CPR coaching pad 48 directs theuser on proper administration of CPR on the patients, includingdirectives to go faster, harder, or to stop compressions. An example ofCPR coaching pad 48 is shown in FIG. 6B. Sensors in CPR coaching pad 48receives CPR data as a user is performing CPR, and generates real-timefeedback to adjust the CPR accordingly so that industry standard timingof CPR and delivery of shock are performed.

Certain embodiments of cardiac pads 13 include sensors therein to detectdata from the SCA patient such as, but not limited to, body impedanceand ECG signals. In certain embodiments, each of cardiac pads 13 includean area 49 that visually/graphically indicates correct placement of suchpad on the patient's body.

Continuing to refer to FIG. 6A and FIG. 6B, fat black arrows indicateAED output to cardiac pads 13, fat open arrows indicate analog datatransfer, and solid arrows indicate digital data transfer. Data from PPGmonitor 46, CPR coaching pad 48, and cardiac pads 13 are gathered andprocessed by a safety processor 50. Once a determination is made thatdefibrillation is appropriate in a given situation, safety processor 50communicates with an AED power and waveform module 51 and a switch andisolation module 52 to initiate and deliver an electric shock to cardiacpads 13. In certain embodiments, safety processor 50 communicates withmobile device 24 through an interface module 53, such as a lightning orUSB connector. Information regarding the patient status, defibrillationinstructions, CPR instructions, emergency services communication, andothers described herein are communicated from the safety processor 50 tothe interface modules 53 using visual and audio cues, such as via a userinterface (UI) speaker 54 and a UI display 55. Safety processor alsocommunicates with a battery and power supervision module 56.

In certain embodiments, portable AED module 30 can be used as astand-alone device, without connection to a mobile device. When usedalone, AED module 30 provides, for example, three electric shocks with abiphasic waveform, each shock with a charge level suitable fortherapeutic use and a delivery time of 1 minute or better at an ambienttemperature of 0° C. from one standard household battery or batterypack, such as a 9V battery. For instance, AED module 30 starts to chargeas soon as AED module 30 is powered on. In certain embodiments, deliveryof the shock occurs within 1 minute of starting the charging sequence,after detection of an appropriate shockable cardiac rhythm. LED icons orindicators 32 located on AED module 30 prompts the user visually andwith audible prompts to guide the user through the appropriate steps ofsetting up AED module 30 for defibrillation, according toindustry-recommended standards. In some cases, AED module 30 directs theuser to initiate CPR, if no pulse is detected from a PPG monitor, whichcan be provided as part of AED module 30, and if no pulse confirmed bythe user. In such a case, certain embodiments of AED module 30 providereal time CPR guidance with feedback, as previously discussed. Incertain embodiments, pressure sensors in AED coaching pad 48 monitorpatient chest recoil during CPR administration. In certain embodiments,AED module 30 coaches the user through the proper rate and depth of CPRusing an impedance sensor and accelerometer. For instance, an XYZaccelerometer, used to measure acceleration and movement of AED coachingpad 48, and a pressure sensor membrane, used to measure active force andrelease of each CPR compression, send CPR-related data to AED module 30via a connector (such as wire 36) to provide user feedback regarding theeffectiveness of the CPR efforts, in accordance with an embodiment. AEDcoaching pad 48 includes, for example, an upper layer stiffener,accelerometer, flex circuit, pressure sensor membrane, and bottom layerstiffener with adhesive, in the embodiment shown in FIG. 6B. In certainembodiments, the guidance provided in the use of AED module 30 adheresto guidelines set forth by industry standard organizations, such as theAmerican Heart Association (AHA) for steps in addressing cardiac arrest.

When an AED module is used with mobile device 24, the above features, aswell as additional features can be provided. In certain embodiments, AEDmodule 30 receives geolocation data from mobile device 24. When AEDmodule 30 is connected with mobile device 24, a software application isautomatically opened. The communication capabilities of mobile device 24can be used to contact EMS (such as “911” in the U.S.) and providelocation data to a dispatcher that receives the communication. In anembodiment, a Short Message Service (SMS) message is sent to EMS oncurrent status of the SCA patient, and continue to update EMS of anychanges to the SCA patient's condition. Information delivered to EMSincludes, but not limited to, details of any shock provided, return ofspontaneous circulation (ROSC), current heart rate, pulse oximeterreadings, and cardiac rhythm status. Providing this information willgive EMS or the hospital the ability to better prepare for neededintervention in care of the specific SCA patient.

FIGS. 7-9 show the steps involved in using a portable AED module, inaccordance with an embodiment. Certain embodiments include initiating anapplication; the application asking if there is an emergency situation;requesting to call emergency services; providing location to EMS via anautomated voice over the device and via text message; automaticallyplacing the open call to the emergency services on speakerphone; placinga PPG monitor; suggesting that CPR should begin if no pulse is detected;checking for pulse confirmation; providing a prompt via audio and visualdisplays on a screen to ensure effective compression is being performed;determining a person providing CPR is fatigued; recommending to changeprovider if low quality CPR is being performed; notifying when analyzingrhythm while CPR is in progress; notifying a person performing CPR andEMS via the speakerphone that a shockable/non-shockable rhythm isdetected; notifying that victim is able to be shocked and advising tostop CPR and not to touch the patient; resuming CPR; recommendingchecking for pulse and responsiveness if PPG monitor detects a pulse andif a viable rhythm is detected; placing the patient in a recoveryposition displayed on the screen; and continuing to monitor the patient.In certain embodiments, an AED module includes other components,including but not limited to a GPS tracker, mobile phone services,modem, and Wi-Fi to communicate with emergency services.

Referring to FIG. 10, an exemplary circuitry for generating a charge fordefibrillation. In certain embodiments, a simplified AED BiphasicTruncated Exponential (BTE) power stage is an energy-based, two stagedesign having a constant current boost charger (e.g., a SEPIC multipliedboost charger) supplying a bulk energy storage capacitor, followed by ahigh voltage full-bridge for steering the positive- and negative-halfphases. FIG. 12 shows an alternative embodiments of an alternative AEDmodule, which includes a tapped inductor boost charger along withfull-bridge steering. In an example, high-voltage and current-sensingfeedback are provided to the microprocessor to prevent incorrect dosingand detect error conditions. Low-voltage ECG sensing stages are isolatedby relays to prevent overvoltage damage during shock delivery. Thecurrent charger uses a low current constant charge rate (in the milliamprange) controlled by pulse-width modulation (PWM) signals from themicroprocessor to charge the energy storage capacitor to the prescribedamount of energy within 60 seconds or less. In an example embodiment, acharge time of approximately 45 seconds or less has been achieved usingfour CR123 batteries as the power source. This length of time and levelof charging current is such that a standard 9V alkaline battery can beused to meet the goal operating time of several hours with at least 6fully rated shocks at full battery conditions and three shocks and 15minutes of operating time at minimum indicated battery level prior toAED use. The output current is steered through the positive and negativephases using, for instance, a high-voltage full-bridge performing hardswitching of the 10-20 ms total duration pulses. The phase transitionstimes are determined based on the body impedance (from 50 ohms to 150ohms), as seen for example in FIG. 11. That is, by adjusting the timingand amplitude of the positive and negative phases, the total energy ofthe shock applied to the SCA patient can be modified for the specificpatient. In an exemplary embodiment, the body impedance is measuredusing the existing wiring of the cardiac pads by sending a low voltagesquare wave across the cardiac pads and calculating the load between thecardiac pads detected when the polarity of the square wave is reversed.

In the example shown in FIG. 11, the waveforms correspond to differenttransition times and amplitudes calculated for different body impedancevalues, in accordance with an embodiment. The total energy applied tothe SCA patient per shock can be calculated using the following Eq. 1:

E=∫ ₀ ^(t) i ² dt  [Eq. 1]

where

${i = {\frac{V}{R} = {current}}},$

R=body impedance, and t=time. In FIG. 11, a waveform 1110 corresponds toR=50 ohms, a waveform 1120 corresponds to R=75 ohms, and a waveform 1130corresponds to R=125 ohms. For instance, as shown, an energy peak of 200J for body impedance of 50 ohms corresponds to a current of i=˜40 Amps.For the example of a charge provided by a 120 microfarad capacitorholding a charge of 1640V, the switching and end times (t₂ and t₃ inFIG. 11) are summarized in TABLE 1.

TABLE 1 Body Switch time t₂ End time t₃ impedance (ohms) (milliseconds)(milliseconds) 25 1.38 4 50 2.76 8 75 4.13 12 150 8.27 24 200 11.02 32

It is important to note that the embodiments described herein requireinnovative solutions to problems not faced by previously available AEDs.For instance, the embodiments described herein provide:

A highly portable AED with a form factor that is much smaller (e.g., thecircuit boards fit within 6-inches by 6-inches by 2-inches in certainembodiments) than that of the commercially-available AEDs;

Circuitry for generating industry-standard biphasic shock from consumerbatteries that are readily available to ordinary users;

The AED being ready to deliver the generated charge to the patientwithin the FDA-required time frame; and

Optionally, the ability for the AED to connect with a mobile device forcommunication with emergency medical services personnel.

These are requirements that go beyond those that have been faced byprevious AED manufacturers.

It is particularly emphasized that, in order to achieve the necessaryperformance from a compact, portable AED from a household battery, thecoordination of the electronic design and firmware is important. It isparticularly emphasized that the generation of shock, and the regulationthereof, powered by a commercially-available household battery andpresented in a user-friendly, compact package at an affordable pricepoint is a significant engineering achievement. There are considerablechallenges in reducing the package size of the AED, especially with thevarious voltage converters and high voltage drivers involved ingenerating the therapeutic shock according to best practices from ahousehold battery. In particular, considerable engineering ingenuity isrequired to achieve the necessary performance under the above listedlimitations, particularly as the operation of the high voltage device byan untrained user involves extensive consideration of safety measuresprovided in the physical features as well as the logic involved in thefirmware and ease of use in the user interface. No device equivalent tothe embodiments described herein is currently known.

The generation of the biphasic waveform from common household batteries,such as one or more 9V or CR123 batteries, is a significant challengedue to the limited voltage and current provided by such batteries. Thecircuitry required to generate an adjustable biphasic waveform, such asthose illustrated in FIG. 11, from household batteries while fittingwithin a highly portable package is a unique challenge solved in theembodiments described herein.

For instance, focusing on the H Bridge shown as “Full-bridge Steering”in FIG. 10, the method used to generate the biphasic waveform in certainembodiments described herein is different from existing designs, such asthose that separately generate the positive and negative phases thencombines them using a time delay circuit when administering to thepatient. In an exemplary embodiment, the biphasic waveform is generatedby discharging a single high voltage capacitor using an H Bridgeconfiguration under microprocessor control.

More specifically, in an exemplary embodiment shown in FIG. 10, switchesM4 and M3 are closed, then opened. Subsequently, switches M5 and M2 areclosed, then opened. Software is used to determine the appropriatetiming of each phase to deliver a total charge of, for instance, 150J inaccordance with Eq. 1 above, with equal charge in each direction of thedecaying resistor-capacitor (RC) potential for each phase (i.e., M4-M3combination, then M5-M2 combination). This exemplary H Bridgeconfiguration allows certain embodiments to generate the requiredbiphasic waveform using only one charge reservoir, thus delivering allof the required charge from the one charge reservoir for bothpolarities. Furthermore, firmware logic is used to prevent erroneouscontrol of the H Bridge (e.g., combinations such as M4-M2 and M5-M3 forthe components shown in FIG. 10). An H Bridge board, such as IXYSH-bridge driver board, is an example of a board that can be configuredas disclosed herein. Additional potential candidates for use in the HBridge configuration are, for example, Powerex modules and Isolated GateBi-polar Transistors (IGBTs), Texas Instruments modules and IGBTs,Infineon PCB modules, CT-Concept/Technologie Power Integrations, IXYSdrivers and IGBTs, and others suitable equivalents.

Another point of innovation for certain embodiments described herein isthe DC-DC converter implementation shown, for example, in FIG. 10 andFIG. 12, capable of enabling capacitor charging within one minute, or aslittle as less than 30 seconds. In an example, the high voltage DC-DCconverter uses a flyback transformer with a forward diode topology.Multiples of such DC-DC converters can be placed in parallel using diodeORing to reduce the charge time, with a trade-off of increasing thecurrent draw from the battery. In an example, the power that can begenerated from a 9V at 1 A is 9 W. If an energy output of 200 Joules,which is equivalent to 200 W*seconds, then this level of energy outputcan be obtained in 200 W*seconds/9 W=22 seconds at 100% batteryefficiency. Efficiency may be less, which could increase the chargetime.

Alternatively, three or four CR123 batteries, which are also readilyavailable with nominal voltage of 3.0V each, may be used in place of the9V battery to supply sufficient charge within the required time frame.In an exemplary embodiment, the circuit design is based upon the use ofa 9V operating at a current of 1 A, which can be achieved with parallelor series combinations of batteries. For instance, parallel combinationsof N 9V batteries will require diode ORing and will supply 1/N currentcapability for each. Series combinations will require each battery to be1/N of 9V and to deliver the full 1 A. CR123 batteries (for example,Energizer Lithium/Manganese Dioxide EL123AP batteries(http://data.energizer.com/pdfs/123.pdf)) can deliver 3V at a continuouscurrent of 1.5 A, and therefore three such CR123 batteries in serieswould meet the criteria.

In certain embodiments, a further variation for the high voltage DC-DCconverter is used in order to more efficiently produce the requiredbiphasic waveform within the FDA-required charge time. This variation isbased on the knowledge that lower voltage DC-DC converters can producehigher current output than higher voltage DC-DC converters becauseconverters are usually designed to put out a fixed amount of power.While a single off-the-shelf DC-DC converter does not provide asufficiently short charge time, a multi-tier approach can be used bydiode ORing the output of multiple DC-DC converters with differentvoltage capacities.

For example, different variants of off-the-shelf DC-DC converters can betiered to yield outputs stepped from 2000V to 4000V from a 12V input. Ifa 9V input is connected to the same configuration, outputs would stepfrom 1500V to 3000V.

This diode ORing concept for faster charging utilizes the lower voltageconverter to deliver higher charging current up to 1500V, and then oneor more of the higher voltage converters to bring the voltage up to thefinal desired value. In other words, rather than using a single, or eventwo, high voltage DC-DC converter, faster charging can be achieved byusing a combination of lower voltage and higher voltage DC-DC convertersin a tiered configuration. A combination of high voltage DC-DCconverters, such as EMCO HV DC-DC converters American Power Designs, andLinearTech DC-DC converters with custom transformer and circuittopologies, can be used to implement the embodiments as disclosedherein.

In certain embodiments, the firmware merges control logic for thecircuitry, as well as impedance measurement across the cardiac pads(i.e., the impedance related to the patient's size) in order to adjustthe parameters of the applied biphasic waveform to the specific patient.As an example, the microcontroller unit (MCU) within the AED serves toprovide overall control of the performance of the AED in a variety ofways.

In an embodiment, the MCU has several responsibilities in the fullyfunctional AED. For instance, the MCU:

1. Delivers a shock as a biphasic waveform with a precise shape,according to precise timing specifications.

2. Monitors an ECG signal, sensed from the cardiac pads, and todifferentiate between “shockable” rhythms and “unshockable” patterns.The associated algorithm runs internally within the AED withoutreal-time access to the cloud, or to any attached device such as asmartphone. Such an algorithm is defined, in the present disclosure, asa shock indicator algorithm (SIA). The specific conditions identifiedrequired for differentiation between shockable and unshockable cardiacrhythms by the SIA follow guidance from industry organizations, such asthe recommendation of ACLS and AHA. In an embodiment, the SIA isprioritized above other processing activities within the AED such thatthe SIA interrupts any other activities in the MCU to commence the shockprotocol, to the exclusion of other activities. Further detailsregarding the SIA are provided hereinafter at the appropriate juncture.

3. Guides users through the shock protocol, such as by displayinginstructions to stand clear, allowing the required amount of time forrescuers to comply with those instructions, and finally triggering theshock itself.

4. Monitors physiological signals pertinent to the determination ofwhether to perform CPR.

5. Monitors the performance of a person administering CPR, includingsensor measurements related to the CPR itself as well as physiologicaldata from the patient, so as to provide guidance to even a lay personwithout CPR training.

6. Connects and communicates with a smart phone, via a wired or wirelessconnection, for enhanced features such as AED and CPR guidance, andcommunication with emergency medical services personnel.

7. Controls certain AED hardware components such as, for example,controlling a charging sequence in preparation for administering ashock.

8. Detects the attachment status of the cardiac pads to the SCA patientsuch that, in the case the cardiac pads are not well-attached to the SCApatient, for example, the AED alerts the user to the condition.

The activities in the above list need not happen simultaneously. Forexample, the device can progress through a charging sequence (item 7above), while providing ECG signal input to the SIA (item 2 above) andalso monitoring the patient for other physiological signs useful to theadministration of CPR (item 4 above), as well as monitoring the user'sCPR performance (item 5 above).

If the SIA indicates that a shock is needed, the MCU continues with thetimed charging sequence (item 7 above), if not yet completed, whilesimultaneously guiding the user through the shock protocol (item 3above) and possibly continuing to monitor physiological signs (item 4above). In an exemplary embodiment, the MCU contains logic such that theadministration of a shock is only commenced when certain criteria arefulfilled. For example, the MCU can be set such that shock isadministered only when: 1) a shock sequence was initiated by the user;2) the charging sequence has been completed; and 3) the shock protocolhas been completed with no alerts, such as due to displaced cardiacpads.

As another example, during the actual administering of a shock, the MCUturns off all other AED activities not essential to that primaryfunction to avoid conflicts and to protect sensitive components.Additionally, after a shock has been administered, the MCU resets someof those other activities to a new-start state, as data gathered priorto the shock may be no longer relevant or accurate.

In an exemplary embodiment, the MCU has several tasks related to theshocking function, including:

1. Monitoring vital signs of the SCA patient and engaging the SIA tolook for a shockable pattern;

2. Guiding the user through the shocking protocol;

3. Managing the charging sequence; and

4. Controlling the shock waveform produced by the AED circuitry.

More specifically, in an embodiment, the MCU provides guidance to theuser, such as to “stand back” or “stay clear” in anticipation of theshock administration, including a protocol to allow the user sufficienttime to comply before administering the shock. The MCU can also providelogic to combine information about, for example, the placement of thecardiac pads on the SCA patient, the readiness state of the hardware(e.g., capacitor charged), and the analysis by the SIA and, if all ofthe requirements are satisfied, instruct the user to stand clear and,after a reasonable time, commence the shock.

In an embodiment, the MCU manages specific timing aspects of thegeneration of the biphasic waveform produced by the AED. For example,the MCU manages a sequence of several carefully timed processes that,once initiated, progress through all the steps in a prescribed order,all the way to completion without interruption. In an exemplaryembodiment, the state machine within the MCU firmware administers thesetting of the timers of various durations, and uses these timers todrive the output pins to control the AED hardware. For instance, thestate machine includes eight unique states with timing on the order ofmilliseconds with a timing precision of 100 microseconds.

In an example, several events are required before a shock isadministered. These include:

1. A “shock needed” signal from the SIA (i.e., a shock request);

2. Completion of guidance sequence, alerting the user to stand back andaway from the SCA patient; and

3. Indication from the circuitry hardware that the charging function hasbeen completed.

These required events happen asynchronously with respect to each other.For example, the shock request can immediately trigger the user alertoperation, or the charging sequence can be set to begin as soon as theAED unit is turned on, such that this step has no direct connection withthe shock request from the SIA. Additionally, the MCU can includefeatures such as, but not limited to:

1. The charging sequence completed (e.g., “HV_Ready”) is a hardwareinterrupt, via an Interrupt Service Routine (ISR);

2. The shock request is a message from one part of the firmware toanother, or from a separate hardware component, if that solution isprovided onboard a processor chip or the like; and

3. The actions to alert the user (e.g., via flashing lights and/or audioalerts) are managed by a clock in the firmware.

As an example, the main loop of the firmware contains the logic to checkthat a shock is required, and that the protocol prior to administeringthe shock (e.g., the user has been alerted to “stand back,” thecapacitors are fully charged) has been completed, and then automaticallyadminister the shock. The firmware main loop managers, for instance: 1)charging requests; 2) shock requests; 3) discharge request to safe state(e.g., if the shock protocol has been aborted); and 4) battery testrequests. Such requests can be presented to the firmware as buttons oras terminal commands. For instance, as buttons, the requests arrive inISRs where minimal logic is allowed (e.g., no terminal output). In anexample, buttons and terminal requests behave the same way; i.e.,instead of direct action, the request is registered in a state variablethat the main loop will check on its next iteration. Such aconfiguration safely allows for feedback to developers via the terminal,while still allowing the ISRs to exit quickly if necessary.

An example process flow of a firmware controlling the AED, in accordancewith an embodiment, is described in FIGS. 13-19.

Referring first to FIG. 13, a relational diagram shows thecommunications between an AED operations control module and otherfirmware within the AED module, in accordance with an embodiment. Asshown in FIG. 13, an AED operations control module (Ops Ctrl) 1305includes circuitry and logic to orchestrate the overall operation of theAED module, such as AED module 10 of FIG. 1. Ops Ctrl 1305 is incommunications a standby power usage management and monitoring module(Stdby) 1310, which manages the operations of the AED module when instandby mode. Stdby 1310 includes circuitry and logic to maintain, forexample, a microprocessor and related circuitry in a low-power mode tofacilitate a longer shelf life for the battery systems within the AEDmodule. When the user activates the AED module for treatment use, Stdby1310 sends Ops Ctrl 1305 a signal 1312 to commence the treatmentoperation of the AED module.

In an embodiment, Stdby 1310 communicates with a charging voltagebattery test module (Charge BTM) 1315, which includes circuitry andlogic to test the battery capacity status of the battery, which powersthe shock generation for the AED module. Periodically, Stdby 1310instructs charge BTM 1315 to check the battery capacity of the mainbattery in the AED module, then send an indication via main batterystatus channel 1316 back to Stdby 1310.

In an exemplary embodiment, Stdby 1310 is also connected with a controlvoltage battery test module (Control BTM) 1320, which tests a controlbattery for powering a microprocessor and related control circuits.Periodically, Stdby 1310 instructs Control BTM 1320 via a controlbattery status channel 1322 to test the capacity of the control battery,then send an indication back to Stdby 1310.

Additionally, in an embodiment, Stdby 1310 communicates with a usernotification module (UI) 1325, which includes circuitry and logic tomanage the conveyance of information to a user regarding devicemaintenance, as well as during AED operation. For instance, if either asignal from main battery status channel 1316 or control battery statuschannel 1322 indicates that the charge of the respective battery is lowand requires replacement or maintenance, Stdby 1310 sends a status alertsignal 1327 to UI 1325 to display an alert indication to notify a userof the problem. UI 1325 also is in direct communications with Ops Ctrl1305 via a UI communication channel 1329 to display user guidance oralerts during the operations of the AED module, as will be explained indetailed as the appropriate juncture below.

Continuing to refer to FIG. 13, in an exemplary embodiment, Ops Ctrl1305 is connected with a pads placement monitoring module (Pads Mon)1330, which includes circuitry and logic to monitor whether a user hasproperly attached a pair of cardiac pads onto the SCA patient. Uponinitiation of the AED operations, and after Ops Ctrl 1305 prompts theuser to place the cardiac pads on the SCA patient via UI communicationchannel 1329 to UI 1325, Ops Ctrl 1305 checks with Pads Mon 1330 via ato ensure the cardiac pads have indeed been properly attached via a padstatus channel 1332. Additionally, Pads Mon 1330 can communicate withOps Ctrl 1305 on an asynchronous basis (indicated by a dashed arrow1334) to alert Ops Ctrl 1305 in case, for example, if a cardiac padbecomes detached from the SCA patient.

Still referring to FIG. 13, Ops Ctrl 1305 is also in communication witha multiple shock protocol management module (Multi-Shock) 1335 via amulti-shock channel 1337, in an embodiment. Multi-Shock 1335 includeslogic to manage situational behavior of the AED in cases where theinitial shock does not result in a return to normal sinus rhythm for theSCA patient. Ops Ctrl 1305 also communicates with an event recordingmodule 1340 via an event recording channel 1342. In an embodiment, eventrecording module 1340 includes circuitry and logic to manage the captureof data related to, for instance, the condition of the SCA patient,therapeutic efforts by the AED, and external communications records.

In an exemplary embodiment, Ops Ctrl 1305 manages a charge/dischargemanagement and monitoring module (Charge Mod) 1345. Charge Mod 1345includes circuitry and logic to manage the charging of the capacitor forstoring the charge to a correct level in order to administer atherapeutic shock. Charge Mod 1345 also includes circuitry and logic tomanage the discharge of the capacitor in the event that a therapeuticshock is not required, such that the AED can be handled safely andreturned to storage in a safe state. Charge Mod 1345 communicates withOps Ctrl 1305 via a charge management channel 1347 to receive andacknowledge, for example, a charge or a discharge command. Also, ChargeMod 1345 can asynchronously communicate its status to Ops Ctrl 1305 (asindicated by a dashed arrow 1349), such as to indicate the capacitorcharge has been reduced to a safe handling level sometime after adischarge command has been received from Ops Ctrl 1305.

In an embodiment, Ops Ctrl 1305 also controls a subjectmonitoring/shockability decision module (Subject Mon) 1350, includingthe SIA. Subject Mon 1350 includes circuitry and logic to manage thegathering of physiological measurements, such as cardiac rhythm, bodyimpedance, and/or ECG signal. Subject Mon 1350 also includes circuitryand logic to analyze the collected data to determine whether the SCApatient's condition is one that requires or can benefit from adefibrillating shock. Ops Ctrl 1305 issues requests to Subject Mon 1350to determine shockability of the SCA patient via a subject monitoringchannel 1352. Whenever a determination of the shockability of the SCApatient has been made, sometime after receipt of the request forshockability determination from Ops Ctrl 1305, Subject Mon 1350 send anindicator back to Ops Ctrl 1305 via an asynchronous communication(indicated by a dashed arrow 1354). Finally, Ops Ctrl 1305 also controlsa shock control module (Shock Ctrl) 1355 via a shock control channel1357. In an embodiment, Shock Ctrl 1355 includes circuitry and logic tomanage the determination of the shock waveform parameters, such as thedurations of the positive and negative components to a biphasic shock,based on analysis of physiological measurements such as body impedance.Shock Ctrl 1355 further includes, in an embodiment, circuitry and logicto produce a biphasic shock waveform, according to the calculatedparameters, then deliver the shock to the cardiac pads placed on the SCApatient. Shock Ctrl 1355 asynchronously sends a communication to OpsCtrl 1305 (indicated by a dashed arrow 1359) to indicate, for example,that a shock has been delivered to the cardiac pads, as well asadditional information such as the waveform parameters and patient vitalsigns.

FIG. 14 shows a standby process flow 1400 showing the firmware processfor AED standby mode, in accordance with an embodiment. Standby processflow 1400 begins when the AED module is brought into service in a step1405. This step may involve, for example, the insertion of a 9V batteryinto the appropriate receptacle, or the removal of an insulating stripfrom the battery compartment to bring the power source in contact withthe rest of the internal circuitry. Then a decision 1407 is made todetermine whether the AED is to be activated in the normal mode ofoperation. If the decision is YES, then Stdby 1310 sends standby signal1312 to Ops Ctrl 1305 to commence normal, non-standby functions of AEDmodule in service, as was also shown in FIG. 13. If decision 1407 is NO,then Stdby 1310 activates the AED module in an On-the-shelf (low power)mode in a step 1410.

While in low power mode, in the embodiment shown in FIG. 14, Stdby 1310is activated on a preset schedule to check the status of the batteriesin a periodic wake-up step 1415. In one aspect, a message 1417 is thensent to a step 1420 in Charge BTM 1315 to check the status of thehousehold battery that is used to charge the capacitor (or multiplecapacitors). A decision 1425 is made at Charge BTM 1315 to determinewhether the charging battery status is okay (i.e., there is enoughcharge left in the charging battery to power the necessary therapeuticshock). Whether the charging battery status is YES okay or NO not okay,the battery status is recorded in a step 1430. Sequentially, or inparallel, a message 1442 is sent to a step 1443 in Control BTM 1320 tocheck the status of a separate battery that is used to power the controlcircuitry in the AED module, in accordance with an embodiment. Adetermination is made in a decision 1445 whether or not the controllerbattery status is okay and, whether the status is YES okay or NO notokay, the battery status is again recorded in step 1430. The status ofboth the charging battery and the controller battery are sent to UI 1325in a step 1450, then displayed to the user in a step 1460.

Considering now FIGS. 15 and 16, an exemplary embodiment of a processthat is started when a signal 1312 to commence the shock protocol of theAED is illustrated. When signal 1312 is received at Ops Ctrl 1305, astep 1505 initializes the AED module for normal operation. In a step1510, a command to place the cardiac pads on the SCA patient is sent toUI 1325, at which an indicator or display message instructs the user toplace the cardiac pads, in a step 1515. Then, in a step 1520, amulti-shock protocol is initialized at Multi-Shock 1335, where“multi-shock” refers to the treatment protocol in which, if certainpreset conditions are met, then a series of shocks can be generated atthe AED module then applied to the SCA patient as needed. Theinitialization of the multi-shock protocol at Multi-Shock 1335 indicatesto Multi-Shock 1335 the start of an emergency session involving an SCApatient, and that future requests for authorization to shock are relatedto this specific SCA patient. Then, in a step 1525, logic to control thenumber of allowed shocks is initialized at Multi-Shock 1335. The logicmay include, for example, an analysis of the number of shocks alreadyapplied, and the current status of the physiological indicators measuredfrom the SCA patient. In a step 1530, a request is made to Multi-Shock1335 to request authorization to apply a shock. The logic withinMulti-Shock 1335 analyzes the request and, in a decision 1540,determines whether to approve the generation and application of a shockto the SCA patient. If the answer to decision 1540 is NO, then theprocess is ended in a step 1542. If the answer to decision 1540 is YES,then the process moves back to Ops Ctrl 1305, as shown in FIG. 16.

Referring now to FIG. 16, a YES result of decision 1540 from Multi-Shock1335 is communicated to Ops Ctrl 1305, at which a step 1605 issues acommand to Charge Mod 1345 to charge the capacitor. At the same time, orsequentially, Ops Ctrl 1305 begins monitoring the patient in a step1607. The monitoring involves, for example, sensing the cardiac padplacement on the SCA patient in a step 1615 at Pads Mon 1330. Thefeedback from the cardiac pads, such as the correct placement of thecardiac pads on the SCA patient, are monitored in a step 1617 at PadsMon 1330, and the results are fed back to a step 1610 to process thevarious monitoring signals. Patient monitoring of step 1607 may alsoinclude monitoring the vital signs of the SCA patient in a step 1620 atSubject Mon 1350. The vital signs, such as cardiac rhythm, are fed backto step 1610 to be monitored. Additionally, Subject Mon 1350 alsodetermines, in a decision 1625, whether or not the detected cardiacrhythm corresponds to a shockable rhythm, as previously described above.If the answer to decision 1625 is YES, then the result is communicatedto step 1610 as part of the signal monitoring. If the answer to decision1625 is NO, then Subject Mon 1350 returns to step 1620 to continuemonitoring the vital signs.

In an embodiment, at Charge Mod 1345, a step 1635 enables the capacitorcharging circuitry, and the capacitor charging status is monitored in astep 1640. A decision 1642 determines whether the capacitor has beensufficiently charged to enable the application of a shock to the SCApatient. If the answer to decision 1640 is YES, then the result iscommunicated to step 1610. If the answer to decision 1640 is NO, thenCharge Mod 1345 returns to step 1640 to continue monitoring thecapacitor charge status.

The monitored signals from step 1610 are then fed into a decision 1645to determine whether both the charging system and the SCA patient areready for the application of a shock. If the answer to decision 1645 isNO, then Ops Ctrl 1305 continues to monitor the incoming signals in step1610. If the answer to decision 1645 is YES, then Ops Ctrl 1305 commandsthe user to stand clear of the SCA patient in a step 1650, which iscommunicated through UI 1325, which instructs the user to stand clearvia a display message or other means in a step 1652. After a set timeperiod, such as 5 to 10 seconds during which the user should have stoodback from the SCA patient, Ops Ctrl 1305 warns the user in a step 1655of the incoming shock, which is communicated to the user in a step 1657at UI 1325. Ops Ctrl 1305 then requests a shock in a step 1660, whichprompts Shock Ctrl 1355 to initiate a shock management protocol in astep 1662. Upon completion of the shock application, Ops Ctrl 1305 goesinto a follow-up protocol step 1665.

Turning now to FIG. 17, further details of the processing performed bySubject Mon 1350, in accordance with an embodiment, are described.Subject Mon 1350, as shown in FIGS. 16 and 17, receives a signal fromOps Ctrl 1305 to begin patient monitoring. When this signal is receivedat Subject Mon 1350, a step 1705 initializes the patient monitoringcircuitry provided with the AED module. For example, sensors forelectrocardiograph monitoring, cardiac rhythm monitoring, andrespiratory rhythm can be included with the AED module. The variousmonitored signals are recorded in a step 1710 at Event Recording Module1330, and also returned to Ops Ctrl 1305 to step 1610 of processing thevarious monitoring signals. The patient vital signs so measured are alsofed into a step 1715 to apply a shockability analysis algorithm, aspreviously described, then to decision 1625 to determine whether the SCApatient is exhibiting a shockable cardiac rhythm.

FIGS. 18 and 19 illustrate further details of step 1662 initiate shockmanagement protocol as shown in FIG. 16, in accordance with anembodiment. The shock management protocol involves the firmware processfor managing a shock protocol and generating an electric shock, inaccordance with an embodiment. When Ops Ctrl 1305 requests a shock to begenerated in step 1660, Shock Ctrl 1355 receives the request andinitializes a body impedance measurement circuit in a step 1805. Then,using sensors in the cardiac pads, for example, or by other measurementmechanism provided with the particular embodiment of the AED module, thebody impedance of the SCA patient is measured in a step 1810. Themeasured body impedance is recorded at Event Recording Module 1340 in astep 1815.

Continuing to refer to FIG. 18, a decision 1820 is made to determinewhether the body impedance measured in step 1810 is within the range inwhich the AED module power circuitry can adjust the shock waveform forsafe application to the particular patient. For instance, if a biphasicwaveform, such as shown in FIG. 12 is to be used for the shock, there isa range of body impedance values for which the AED module is able toaccommodate and adjust the waveform parameters for application of shockwithin American Heart Association guidelines. If the measured bodyimpedance is lower (i.e., the SCA patient is too small) or higher (i.e.,the SCA patient is too large) than the range of allowable body impedancevalues, then Ops Ctrl 1305 is so notified in a step 1825 and no shock isadministered. Shock Ctrl 1355 then instructs UI 1325 to display an errormessage in a step 1830, and UI 1325 accordingly displays an errormessage for the user in a step 1832.

If decision 1820 determines that the measured body impedance is withinthe range for which a suitable waveform can be generated, then thenecessary waveform parameters are calculated in a step 1840. Step 1840involves, for example, uses an algorithm that, given vital signmeasurements from the patient such as, but not limited to, bodyimpedance, cardiac rhythm, and ECG data, calculates the appropriatetiming and amplitudes of the positive and negative phases of thegenerated waveform, as shown in previously discussed FIG. 11. Thecalculated waveform parameters are recorded at Event Recording module1340 in a step 1845, then instructions are sent to the high voltagedrivers in the AED module to power up in a step 1850.

Referring now to FIG. 19, once the high voltage drivers are powered upin step 1850, Shock Ctrl 1355 instructs the high voltage drivers togenerate a timed positive phase component of a biphasic waveform shockin a step 1905. Shock Ctrl 1355 monitors the generation of the timedpositive phase component and, in a decision 1910, determines whether thegeneration of the timed positive phase component is complete. Ifdecision 1910 determines that the high voltage drives have not completedthe generation of the timed positive phase component, then Shock Ctrl1355 continues to monitor the high voltage drivers. When the result ofdecision 1910 is YES, then Shock Ctrl 1355 instructs the high voltagedrivers to generate the timed interphase, or quiescent, componentbetween the positive and negative phases of the biphasic waveform in astep 1915. Again, Shock Ctrl 1355 monitors the generation of the timedinterphase component and, in a decision 1920, determines whether thegeneration of the timed interphase component is complete. If decision1920 determines that the timed interphase component generation is notyet complete, then Shock Ctrl 1355 continues to monitor the high voltagedrivers. When the result of decision 1920 is YES, then Shock Ctrl 1355instructs the high voltage drivers to generate the timed negative phasecomponent in a step 1925. Yet again, Shock Ctrl 1355 monitors thegeneration of the timed negative phase component and, in a decision1930, determines whether the generation of the timed negative phasecomponent is complete. If decision 1930 determines that the timednegative phase component generation is not yet complete, then Shock Ctrl1355 continues to monitor the high voltage drivers. When the result ofdecision 1930 is YES, then Shock Ctrl 1355 instructs the high voltagedrivers to power down in a step 1935 and proceeds to the follow-upprotocol at Ops Ctrl 1305. The details of the shock event are alsorecorded at Event Recording Module 1340 in a step 1940.

In another embodiment, the portable AED is configured to be housed in abracket, which is mountable on a wall or other location. The bracket caninclude, for example, a connection to a power outlet such that thebracket can serve as a charging station for the AED, if a rechargeablebattery is used within the AED module, or to provide additionalfunctions. For instance, the bracket provides a monitoring function forthe AED so as to alert the user, e.g., via a visual warning on thebracket or communication through the associated mobile deviceapplication or user webpage, in the case of situations such as: 1) theAED has been removed from the bracket; 2) a battery in the AED is lowand needs to be replaced; and 3) the AED has a problem and needs to beserviced. The bracket can also include a button, either a physicalbutton or on a touch screen, to immediately alert EMS or other contactsprogrammed into the mobile device application in the case of anemergency.

An exemplary embodiment of a bracket is shown in FIG. 20. A bracketsystem 2000 includes a bracket body 2010, which in turn includes one ormore lips 2012 (three are shown in the embodiment illustrated in FIG.20) for housing an AED module (not shown) when the AED module is not inuse. In the example shown in FIG. 20, bracket system 2000 includes anemergency call button 2020, which can be pressed by a user toimmediately contact emergency medical services (e.g., via a 911 call inthe US). Alternatively, call button 2020 can be replaced by atouchscreen including an emergency call function as well as beingcapable of displaying additional information, such as the AED batterystatus and AED user guidance. Call button 2020 (or a touchscreenequivalent) can also be configured to alert specified contactsprogrammed into a software application installed on a mobile device. Forinstance, the firmware in bracket system 2000 can be configured toautomatically contact EMS as well as specified contacts (e.g., relativesand friends) programmed into the software application on a mobile devicepaired with bracket system 2000.

Bracket system 2000 also includes a sensor 2022 for detecting whetherthe AED module is housed in bracket body 2010. For instance, when theAED module is housed in bracket body 2010, sensor 2022 detects thepresence of the AED module such that bracket system 2000 remains in alow power mode. When the AED module is removed from bracket system 2000,then bracket system 2000 goes into an active mode, in which certainfunctions of the bracket system 2000 are activated. Optionally, bracketsystem 2000 can be configured such that, when sensor 2022 detects thatthe AED module has been removed from bracket system 2000, bracket system2000 automatically prompts the user to contact EMS or even immediatelycontact EMS without additional user input.

As shown in FIG. 20, bracket system 2000 also includes an indicator2024, which can be used to show the user the status of a Wi-Ficonnection or cellular signal strength, if bracket system 2000 isconfigured to be connectable to an external communication system.Bracket system 2000 also includes a microphone 2030 and a speaker 2035to facilitate hands-free communications with EMS via bracket system2000. For instance, when the AED module is removed from bracket system2000, bracket system 2000 automatically alerts EMS that there is anemergency situation, and also prompts the user by audio (as shown inFIG. 20) or by visual prompt (e.g., if a touchscreen is used instead ofemergency call button 2020). As an example, the removal of the AEDmodule from bracket system 2000 leads to bracket system 2020automatically contacting EMS and generating a voice prompt 2037 to theuser. As an option, a lag time of, for instance, one minute may be givenbetween the time the AED module is removed from bracket system 2000 towhen EMS is contacted such that, if the AED module is accidentallyremoved, the user is given time to replace the AED module and avoidunnecessarily contacting EMS.

FIGS. 21-23 illustrate an exemplary embodiment of a portable AED modulehaving features as described above. A portable AED module 2100 hasdimensions of approximately 8-inches by 6-inches by 3-inches, and isshown in ISO, side, and bottom views in FIGS. 21-23, respectively. Asshown in the exemplary embodiment, portable AED module 2100 is poweredby a battery arrangement 2110 including a plurality of batteries 2112.In the embodiment shown in FIGS. 21-23, batteries 2112 are four CR123batteries, which are commonly-available household batteries. AED module2100 also include various connection ports 2120 and 2210 that provideconnections for the cardiac pads, as well as test inputs and outputs.Outer enclosure 2150 of portable AED module 2100 is configured tominimize the risk of shock to the user, as well as to protect theinternal electronic circuitry of the AED module from hazards, such aselectrostatic discharge (ESD) and moisture. Portable AED module 2100further includes a plurality of button switches 2170 for accessingvarious functionalities of portable AED module 2100, as well as servingas status indicators by color coded illumination of the button switches.Using a single household 9V alkaline battery, a high voltage of 1700Vwas achieved in 48 seconds, without current limiting, on the firstcharge cycle, and in 55 seconds, with current limiting for safety andbattery power conservation. Embodiments replacing the 9V battery withfour CR123 batteries in series have been demonstrated to achieve evenfaster charge times around 30 seconds using custom circuitry.

Turning now to FIG. 24, an example of an electronics architecture 2400suitable for use with a portable AED module, in accordance with anembodiment, is shown. Electronics architecture 2400 includes amicrocontroller 2410 (equivalent to microprocessor 20 of FIG. 2)overseeing the operations of a logic control circuit 2420. Power tomicrocontroller 2410 and logic control circuit 2420 are supplied via alogic supply circuit 2430 from a dedicated controller battery 2435,which is separate from a battery used to generate the therapeutic chargein the portable AED module, such that the controller operations do notdrain the charge battery. The power source for the actual chargegeneration is a charge battery 2450, which is shown as a 9V battery inFIG. 24, although other types of household batteries can be used aswell. A current limiter 2455 adjusts the current drawn from chargebattery 2450 for the charge generation. Current from charge battery 2450is directed through a high voltage DC-DC converter 2460, from which theoutput is used to charge a high voltage capacitor 2465. Logic controlcircuit 2420 provides the necessary logic for safely operating highvoltage DC-DC converter 2460, as well as discharging high voltagecapacitor 2465, if the generated charge is not needed or the operationof the portable AED module is interrupted. The charge stored in highvoltage capacitor 2465 is output to the cardiac pads (shown in FIG. 24as “paddles”) via an H Bridge 2470 controlled by an H Bridge driver2475, which in turn is controlled by logic control circuit 2420. HBridge driver 2475 controls the generation of the appropriate shockwaveform, such as a biphasic waveform, with the appropriate waveformparameters suitable for the specific SCA patient, as indicated by vitalsigns measurements. Electronics architecture 2400 is suitable for use,for example, with the firmware configuration described in relation toFIGS. 13-19.

Referring now to FIG. 25, an exemplary AED including an AED operationsblock and a communication block, in accordance with an embodiment, isillustrated. AED 2500 includes features that allow AED 2500 to beconnected with the outside world so as to provide additionalfunctionality and allow use scenarios that have been heretoforeimpossible. An AED 2500 includes an AED operations block 2502, whichincludes various components that enable AED 2500 to generate anddeliver, within regulatory guidelines, an electric shock to a person inSudden Cardiac Arrest. As shown in the embodiment illustrated in FIG.25, AED operations block 2502 includes a controller 2510, whichregulates a variety of components including an electrocardiogram (ECG)monitoring circuitry 2520, which is in turn connected with pads 2522.Pads 2522 are configured for attachment to specific locations on the SCApatient for both obtaining ECG signals and administering the electricshock generated by shock generating electronics 2524, which is alsocontrolled by controller 2510.

Additionally, AED operations block 2502 includes a power managementblock 2530, which is also controlled by controller 2510 in anembodiment. Power management block 2530 is configured for managing thepower consumption by various components within AED operations block2502. For instance, power management block 2530 monitors a charge statusof a battery 2532, which provides power to shock generating electronics2524. As such, controller 2510 can alert the AED user if a low batterylevel is detected by power management block 2530. Similarly, controller2510 can also regulate power management block 2530 to control the on/offstatus of other components within AED 2500 so as to minimize the powerconsumption by these other components while the AED is not being used.In an embodiment, for example, power management block 2530 is configuredto completely power down ECG monitoring circuitry 2520 and shockgenerating electronics 2524 when the AED is not being used.

Continuing to refer to FIG. 25, controller 2510 is also connected with amemory 2540, which stores information regarding AED 2500, such as usehistory, battery status, shock administration and cardiopulmonaryresuscitation (CPR) protocols, and other information used in theoperation of AED 2500.

Controller 2510 further controls a user-interface (UI) block 2550. UIblock 2550 includes, for example, voice and/or visual prompts forinstructing the AED user on the use of AED 2500 as delivered by, forinstance, a haptic display such as a touch screen, light emitting diode(LED) indicators, liquid crystal display, speakers, switches, buttons,and other ways to display information to the user and/or for a user tocontrol the AED. In an embodiment, UI block 2550 can optionally includea microphone to receive voice inputs from the AED user. In analternative embodiment, UI block 2550 can optionally include aninterface with an external application, such as a native or web app on amobile device configured for communicating with AED 2500.

Still referring to FIG. 25, AED 2500 includes a communications block2570, also controlled by controller 2510. Communications block 2570provides connections to external systems and entities outside of theAED, such as emergency medical services, hospital emergency rooms,physicians, electronic health record systems, as well as other medicalequipment, such as ventilators and an external ECG. In an embodiment,communications block 2570 includes, a cellular modem 2572 and aBluetooth modem 2574. Optionally, communications block 2570 alsoincludes, for example, a Wi-Fi modem 2576 for providing wirelessconnection to and from an external device, one or more wired connections2578 for providing direct wired connection to AED 2500 such as via alocal area network (LAN), cable, phone line, or optical fiber.Communications block 2570 can also optionally include a satellite modem2580 for providing remote communications via satellite. The variouscommunication modes within communications block 2570 are configured tocomply with regulatory guidance related to wireless technology, such ascoexistence, security, and electromagnetic compatibility. By having asingle controller (e.g., a microprocessor) control the various blockswithin AED 2500, the circuit design and firmware configuration of AED2500 is greatly consolidated over other AEDs with multiple processors,while enabling a reduction in power consumption of the device.

The combination of AED operations block 2502 and communications block2570 enables a variety of new uses for exemplary AED 2500. FIG. 26 showsa block diagram of communications interconnections enabled bycommunications block 2570 of exemplary AED 2500 shown in FIG. 25, inaccordance with an embodiment. Communications block 2570 providescommunications capabilities to AED 2500 so as to expand the usability ofAED 2500. In an embodiment illustrated in FIG. 26, communications block2570 is connected with cloud 2610, which provides an internet-basedcommunication platform. In the example shown in FIG. 26, cloud 2610provides a way for communications block 2570 to communicate with aserver 2612 located, for instance, at the company that provides AED2500. Communication with cloud 2610 can be performed, for instance,using cellular modem 2572, Bluetooth modem 2574, Wi-Fi modem 2576, wiredconnection 2578, and/or satellite modem 2580 as described in referenceto FIG. 25. Wired connection 2578 includes, for instance, a cable line,a phone line, an optical fiber, and/or an electrical wire, where thewired connection forms, for example, a local area network.

Through cloud 2610, server 2612 provides to communications module 2570,and thus AED 2500, a variety of data such as software and firmwareupdates, modifications to the shock administration and CPR guidance,device registration information, patient account information, presenceof other nearby AEDs, and help files for error remediation if somethingis wrong with AED 2500. Similarly, AED 2500, through communicationsmodule 2570, provides to server 2612 additional information such as, forexample, device registration status, battery status, device use history,device error log, and device location.

Continuing to refer to the embodiment illustrated in FIG. 26,communications module 2570 is also configured to communicate with amobile device 2620 using, for example, cellular modem 2572, Bluetoothmodem 2574, Wi-Fi modem 2576, of satellite modem 2580, as shown in FIG.25. As an example, a native or web app is installed on mobile device2620 enables a user to perform AED-related tasks such as registration ofthe AED with the AED provider, and access to AED information andtutorials related to AED use. Optionally, mobile device 2620 isconnected to cloud 2610 so as to be able to connect with server 2612therethrough, thus enabling the user to access data available at server2612. For instance, through an app installed on mobile device 2620, auser can register an AED device, update personal account information,access training videos, verify the status and use history of an AEDdevice, download treatment protocol and software updates, selectlanguage options, and/or locate nearby AED devices that have also beenregistered with server 2612. Mobile device 2620, through a native or webapp installed thereon, can optionally be configured to contact emergencymedical services (EMS) such as 911 dispatch, nearby hospitals, andphysicians, as indicated by a box 2630, automatically or when promptedby a user. Cloud storage can also be accessed in order to store AEDusage and other information in virtual storage.

Other components can also be accessed by AED 2500 through communicationsblock 2570. For instance, AED 2500 can be mounted in a bracket 2640configured for providing additional or supplemental communications,power charging, and/or user interface functions to the AED. An exampleof such a bracket is disclosed in U.S. patent application Ser. No.15/847,826 entitled “Automatic External Defibrillator Device and Methodsof Use,” filed on Dec. 19, 2017. Communication block 2570 communicatesdirectly with bracket 2640 wirelessly or through a wired connection.Bracket 2640 can in turn provide a communication link to, for instance,cloud 2610, mobile device 2620, EMS 2630, and/or networked hardware2650, such as other AEDs, other external medical devices (e.g., pulseoximeter, ECG, CPR tracker), wearable devices (such as fitness trackersand heart monitoring consumer equipment, such as an Apple watch or aWhoop tracker) and a desktop or laptop computer. Networked hardware 2650can also be configured to directly communicate with AED 2500 viacommunications block 2570. As shown in FIG. 26, AED 2500 may alsodirectly access mobile device 2620, EMS 2630, bracket 2640, networkedhardware 2630, and/or cloud 2610 via communications block 2570.

It should be noted that direct communications between AED 2500 and EMS2630 may provide additional advantages. While AED 2500 is a regulateddevice subject to regulatory approval by a governing body such as theFederal Drug Administration (FDA), any other peripheral device connectedwith AED 2500 and essential for the operation of AED 2500 as alife-saving device may also come under regulatory scrutiny. For example,if communications with EMS 2630 is only allowed to go through, forexample, cloud 2610 and/or mobile device 2620, then cloud 2610 and/ormobile device 2620 may also be subject to FDA approval as a medicaldevice. Instead, by enabling direct communication between AED 2500 withEMS 2630, only components and software within AED 2500 would beconsidered a standalone FDA regulated medical device, while cloud 2610and mobile device 2620 would be considered peripheral data conduitsonly.

Having a variety of communications options, from cell modem, Bluetoothmodem, Wi-Fi modem, wired connection, and satellite modem (optional) ina single AED allows a variety of communication modes such that, if theAED is placed in a location without one or more of the communicationservices, other communication modes can be used to ensure theconnectivity of the AED. For instance, if AED 2500 is placed is locatedwhere Wi-Fi is not available, it will likely be able to still send andreceive information via one of the other communication modes, such ascell modem 2572 or Bluetooth modem 2574. Also, AED 2500 may beconfigured for compatibility with Bluetooth- or radio frequencyidentification (RFID)- or near infrared (NIR)-based accessories, such asTile Bluetooth trackers or the like, such that AED 2500, throughcommunications block 2570, is able to communicate with other deviceswith such Bluetooth-based accessories. For instance, if several AEDshave been tagged with compatible Tile trackers, each AED 2500 may beconfigured to enable “pinging” and locating other devices on a meshnetwork. Furthermore AED 2500 may be configured for compatibility with“smart home” applications such as Alexa or Nest. For instance, when AED2500 communicates with EMS 2630 to direct emergency services personnelto a sudden cardiac arrest incident in progress, AED 2500 cansimultaneously communicate with the smart home application to ensure thehouse lights are on, doors are unlocked or garage doors are opened forEMS access, etc. Such tracker accessories and smart home applicationsmay be implemented as part of networked hardware 2650 in FIG. 26. Asanother embodiment, rather than relying on GPS satellite data forlocating AED 2500, cellular modem 2572 may be used for providinglocation information of AED 2500. For example, cellular modem 2572 mayinclude the necessary firmware and/or hardware for compatibility with acellular-based locator service, such as those provided by Polte orQuectel, which allows for cellular triangulation of devices as well asz-axis (i.e., height/altitude) location.

Exemplary embodiments of AED operations enabled by the communicationscapabilities provided by communications block 2570 are illustrated inFIGS. 27-30. FIG. 27 shows a flow diagram illustrating an exemplaryprocess flow for using the exemplary AED to treat a person experiencingSCA, in accordance with an embodiment. The interactions between actionstaken by the user of the exemplary AED, actions initiated by theexemplary AED, and the displayed prompts at a user interface (UI) as aresult of the user and AED actions are shown in the flow diagram of FIG.27. UI includes, for instance, an LED display, a touch screen, a liquidcrystal display, switches, buttons, and other ways to displayinformation to the user and/or for a user to control the AED.

More specifically describing the various components shown in FIG. 27,the AED begins in a standby mode 2702. When a user is ready to use theAED, for instance when a person nearby is experiencing SCA, the useractivates the AED in a step 2704 by pressing the on switch or,optionally, removing the AED from a bracket. Upon activation, the AED isprompted to run a self-check of its status in a step 2706. The resultsof the AED status self-check and instructions for AED use are thendisplayed at the UI in a step 2708, starting with a prompt to open acompartment on the AED containing the cardiac pads for attaching to theSCA patient. Upon sensing the user opening the pads compartment in astep 2710, the AED begins charging the shock generation circuitry in astep 2712. Then, instructions on the placement of the cardiac pads onthe patient is displayed at the UI in a step 2714. If the AED is beingused in a true SCA emergency, the user attaches the cardiac pads to thepatient in a step 2716. In an exemplary embodiment, the cardiac pads areconfigured for being the conduit for the delivery of electric shock fromthe AED, and are also capable of detecting the patient heartbeat to beinput into an electrocardiogram (ECG) software in the AED.

Still referring to FIG. 27, the AED then determines whether the padshave been attached to the patient (e.g., whether or not an open circuitis detected between the AED and the cardiac pads) in a decision 2718. Ifthe answer to decision 2718 is NO, then an error message is displayed atthe UI in a step 2720, prompting the user to check that the cardiac padsare properly attached to the SCA patient. If the AED determines in astep 2722 that the cardiac pads are still not attached to the patient,then the shock generation circuitry (including, e.g., a capacitor) isdischarged to a safe, standby level in a step 2724. A message regardingthe circuit discharge is displayed on the UI in a step 2726, and the AEDreturns to standby mode 2702.

If the answer to decision 2718 or decision 2722 is YES, the cardiac padsare properly attached to the patient, then the AED initiates acommunications protocol in a step 2730. As an example, communicationsprotocol includes contacting EMS, prompting a bracket to contact themain server through the cloud, or initializing networked hardware, asshown in FIG. 2. In the example shown in FIG. 27, AED contacts EMS inthe communications protocol step 2730, then displays a notice to theuser regarding the EMS notification (such as, for example, a visualdisplay showing “Emergency personnel have been contacted”) in a step2732.

Continuing to refer to FIG. 27, the AED then monitors the ECG readingsof the SCA patient via the cardiac pads in a step 2734. The AED makes adetermination whether a normal heart rhythm is being detected from thepatient in a decision 2736. If a normal heart rhythm is detected indecision 2736, then the process return to step 2734 to continue tomonitor the ECG readings. If the answer to decision 2736 is NO, thedetected heart rhythm is not normal, then a determination is made in adecision 2738 whether the detected heart rhythm is a shockable rhythm,in accordance with current medical guidelines. If the answer to decision2738 is NO, the detected heart rhythm is not a shockable rhythm, thenthe process returns to step 2734 to again monitor the ECG readings.

If the answer to decision 2738 is YES, the detected heart rhythm is ashockable rhythm, then in a step 2740 the UI displays a message to theuser that the delivery of a shock is advised and the user should not betouching the patient. At this point, the user should release contactwith the SCA patient, in a step 2742. The AED waits a preset amount oftime (e.g., X seconds) in a step 2744 prior to administering a shock tothe SCA patient via the cardiac pads in a step 2746. Followingadministration of the shock, the AED displays instructions in a step2748 for the user to perform CPR on the SCA patient, as is currentlyrecommended by the American Heart Association. While the user performsCPR in a step 2750, the AED returns to monitoring of the ECG in step2734 in order to determine if another round of shock may be necessary.

It is noted that, in the exemplary embodiment illustrated in FIG. 27,once the user properly attaches the cardiac pads to the SCA patient, theAED operations do not require any user intervention until after a shockhas been delivered. Additionally, as updates to American HeartAssociation or Food and Drug Administration recommendations are issued,the settings in AED operations block 2502 is updated via communicationsblock 2570 in a manner transparent to the user.

FIG. 28 shows a flow diagram illustrating an exemplary process flow forperforming a status check and error remediation for an exemplary AED, inaccordance with an embodiment. Like in FIG. 27, the interactions betweenactions taken by the user of the exemplary AED, actions initiated by theexemplary AED, and the displayed prompts at a UI as a result of the userand AED actions are shown in the flow diagram of FIG. 27. The processshown in FIG. 28 is a periodic self-check process, which is notdependent on user action, unless an error is found during theself-check. If an error is found, then user intervention is solicited inorder to remedy the error.

Continuing to refer to FIG. 28, the AED begins in standby mode 2702, asin FIG. 27. Then, without user input, the AED performs a self-check in astep 2804. Self-check 2804 is prompted, for example, by a periodic“wake-up” call by controller 2510 integrated into an internal clock. Forexample, the AED is programmed to automatically run a self-check everythree to seven days. Following the self-check step 2804, a determinationis made in a decision 2806 to see if the AED status is OK. If the answerto decision 2806 is YES, AED status is OK, then the OK status is sent tothe server (e.g., server 212 as shown in FIG. 2) via communication block2570 in a step 2808, and the AED returns to standby mode 2702.

If the answer to decision 2806 is NO, AED status is not OK, then anerror status is sent to the server in a step 2810, and the AED goes intoan alert mode in a step 2812. The UI is directed to display an AEDstatus alert in a step 2814, prompting the user to take action, such asto click the “INFO” button on the AED UI. The UI can include, forexample, one or more flashing LED lights indicating an error status.Once the user performs the action, such as to click the “INFO” button ina step 2816, the AED identifies the specific error that caused the errorstatus in a step 2818, and displays the remedy instructions, if known,at the UI in a step 2820. Step 2820 can include the display of a messagesuch as “Unknown error—contact the AED provider” in case of an errorthat is not identifiable by the AED. Once the user follows the UIdisplayed instructions in a step 2822, the AED returns to the self-checkstep 2804. When no error is found after repeating the processillustrated in FIG. 28, the AED returns to standby mode 2702.

A variation of the self-check process in FIG. 29 shows a flow diagramillustrating an exemplary process for performing a status check anderror remediation for an exemplary AED using an auxiliary application,in accordance with an embodiment. In the example shown in FIG. 29, theuser performs some of the user actions using a native or web-basedapplication (e.g., App UI) on a mobile device such that at least some ofthe error remediation actions can be performed even if the user is notin close proximity to the AED. The interactions between actions taken bythe user of the exemplary AED, actions initiated by the exemplary AED,and the displayed prompts at a user interface (UI) as a result of theuser and AED actions are shown in the flow diagram of FIG. 29.Additionally, actions at the server are also included in FIG. 29.

Continuing to refer to FIG. 29, like the process illustrated in FIG. 28,the AED begins in standby mode 2702, as in FIG. 27. Then, the AEDperforms a self-check in step 2804, then a determination is made indecision 2806 to see if the AED status is OK. If the answer to decision2806 is YES, AED status is OK, then the OK status is sent to the servervia communication block 2570 in step 2808, where the AED status recordis updated in a step 2910. If the answer to decision 2806 is NO, the AEDis in an error status, then the error status is sent to the server viacommunication block 2570 in step 2810, where again the AED status recordis updated in step 2910.

At the server, a determination is made in a decision 2912 to determinewhether or not the latest status update involves an error status. If theanswer to decision 2912 is NO, no error status was reported from the AEDin the latest update, then an OK status is displayed at the UI in a step2914, and the AED returns to standby mode 2702. The UI in this case is adisplay on the user application. If the answer to decision 2912 is YES,the AED most recently reported an error status, then the AED goes intoan error mode in a step 2920, generating an alert indicator at theapplication UI in a step 2922, prompting the user to open theapplication on their mobile device in a step 2924. When the user opensthe application, the server is prompted to locate the status record ofthe specific AED in a step 2926. Once the status record has beenlocated, the current AED status is displayed in the application UI in astep 2928, prompting the user to request more information. The userrequests repair instructions in a step 2930, for example, by clicking ona menu option in the application UI. The request for repair instructionsfrom the user prompts the AED to begin its repair mode in a step 2932,and directs the application UI to display the relevant repairinstructions in a step 2934 to mitigate the status error. Once the userfollows the repair instructions in a step 2936, the AED is returned tothe self-check step 2804 to repeat the process until no error status isfound and the system returns to standby.

It is noted that the status check and user alert processes illustratedin FIGS. 28 and 29 are enabled by the implementation of the AEDoperations block and the communications block within the exemplary AED.The interconnection of the AED operations with the communicationscapability provided by the communications block enables the real-timestatus updates and alerting of the user to ensure any problems or errorsexperienced at the AED can be quickly remedied by the user.Additionally, the AED provider can also proactively contact the user orperform diagnostics on the connected AED, such as that illustrated inFIGS. 25 and 2 without having to wait for a user to notice an alert.

In cases where multiple connected AEDs are deployed, additional usescenarios can be implemented. For example, FIG. 30 shows a flow diagramillustrating an exemplary process flow for locating nearby AEDs using anauxiliary application, in accordance with an embodiment. In theillustrated case, if a registered user of the connected AED witnessessomeone experiencing SCA, the user can use the AED application on theirmobile device to locate a nearby AED also on the AED network. FIG. 30illustrates the interactions between user-initiated actions, the actionsat the auxiliary application, such as a native or web application on amobile device, and the user interface connecting the user and theapplication.

Continuing to refer to FIG. 30, if a user is not carrying an AED yetneeds to locate one quickly, such as if the user is witnessing someoneexperiencing SCA, then the user can open the auxiliary application ontheir mobile device in a step 3002. The application initializes in astep 3004, then prompts the UI to display a menu of options in a step3006, including the option to “Find an AED.” When the user selects the“Find an AED” option, the app contacts the server in a step 3010 to findany AEDs registered to the network. The application UI then displays amap of available, registered AEDs in a step 3012. At the same time, theapplication can also activate location indicators on the available,registered AEDs in a step 3014 such that they are more easily found. Forinstance, the identification of a particular AED on a map generatedduring the “Find an AED” process can cause the located AEDs to startflashing an indicator LED, generating a noise, or display other ways ofalerting its availability to potential users. The user can then locateand retrieve an AED in a step 3016, then begin using the AED on thepotential SCA victim in a step 3018.

In an exemplary embodiment, the AED is paired with a bracket, as shownin FIG. 31. A bracket 3100 is configured for supporting AED 2500 thereonby using, for example, arrangements such as hooks, plugs, frames, oranother mechanical apparatus. Bracket 3100 includes, for instance,communications devices such as a cellular modem 3102, Bluetooth modem3104, Wi-Fi modem 3106, wired connection 3108, and/or satellite modem3110. Bracket 3100 can also be directly connected with a phone line,which may be an electrical or optical communication line. If arechargeable battery with wireless charging capability (optional) isincluded in AED 2500, bracket 3100 can also include a wireless charger3114. Additionally, bracket 3100 also optionally includes an AC and/orDC power connection 3116 such that the bracket, and potentially AED2500, is provided with power directly from a wall outlet or a 12V DCoutlet in a vehicle.

The communications devices within bracket 3100 augments thecommunications capabilities of communications block 2570 of AED 2500,for example, by enabling alternative ways of connecting AED 2500 withexternal devices. Also, as bracket 3100 is installable on a wall in abuilding or moving vehicle (e.g., automobile, ambulance, airplane,submarine, or ship) and doesn't require the same level of portability asthe AED itself, components that may not easily fit within the formfactor of the AED can be housed within the bracket in order to extendthe functionality of the AED when the AED is paired with the bracket.For instance, the bracket can provide additional processing orcommunications functionality that may not fit within the AED due to sizeand power constraints. As an example, the bracket with communicationscapabilities can be configured to automatically alert EMS and/or AEDmanufacturer when the AED is removed from the bracket. Also, additionalstatus indicators and UI elements can be included in the design of thebracket to supplement the UI capability of the AED. In this way, the AEDdesign can be focused on compactness and ruggedized portability,designed to protect the critical components with vibration protectionand a watertight seal (e.g., IP67 or IP68 compliant), as well as beingable to withstand extreme cold and heat.

Although a few exemplary embodiments have been described, those skilledin the art will readily appreciate that many modifications are possiblein the exemplary embodiments without materially departing from the novelteachings and advantages of the embodiments described herein. Forexample, certain functions and processes can be automated such thatspecific actions occur upon receipt of predefined triggers. Forinstance, the AED system can be configured to immediately contact theserver as soon as the AED is removed from its bracket, thus alerting theserver that the AED will soon be used in an emergency situation or theAED may have been removed without authorization. The server then candirectly ping the AED administrator's mobile device to confirm whetherthe AED removal was intentional and authorized.

The illustrations of arrangements described herein are intended toprovide a general understanding of the structure of various embodiments,and they are not intended to serve as a complete description of all theelements and features of apparatus and systems that might make use ofthe structures described herein. Many other arrangements will beapparent to those of skill in the art upon reviewing the abovedescription. Other arrangements may be utilized and derived therefrom,such that structural and logical substitutions and changes may be madewithout departing from the scope of this disclosure. Figures are alsomerely representational and may not be drawn to scale. Certainproportions thereof may be exaggerated, while others may be minimized.Accordingly, the specification and drawings are to be regarded in anillustrative rather than a restrictive sense.

In the foregoing specification, specific embodiments have beendescribed. However, one of ordinary skill in the art appreciates thatvarious modifications and changes can be made without departing from thescope of the described embodiments as set forth in the claims below.Accordingly, the specification and figures are to be regarded in anillustrative rather than a restrictive sense, and all such modificationsare intended to be included within the scope of present teachings. Thedescriptive labels associated with the numerical references in thefigures are intended to merely illustrate the embodiments, and are in noway intended to limit the described embodiments to the scope of thedescriptive labels. The present systems, methods, means, and enablementare not limited to the particular systems, and methodologies described,as there can be multiple possible embodiments, which are not expresslyillustrated in the present disclosures. It is also to be understood thatthe terminology used in the description is for the purpose of describingthe particular versions or embodiments only, and is not intended tolimit the scope of the present application.

Some embodiments, illustrating its features, will now be discussed indetail. The words “comprising,” “having,” “containing,” and “including,”and other forms thereof, are intended to be equivalent in meaning and beopen ended in that an item or items following any one of these words isnot meant to be an exhaustive listing of such item or items, or meant tobe limited to only the listed item or items. It must also be noted thatas used herein and in the appended claims, the singular forms “a,” “an,”and “the” include plural references unless the context clearly dictatesotherwise. The disclosed embodiments are merely exemplary.

Accordingly, many different embodiments stem from the above descriptionand the drawings. It will be understood that it would be undulyrepetitious and obfuscating to literally describe and illustrate everycombination and subcombination of these embodiments. As such, thepresent specification, including the drawings, shall be construed toconstitute a complete written description of all combinations andsubcombinations of the embodiments described herein, and of the mannerand process of making and using them, and shall support claims to anysuch combination or subcombination.

What is claimed is:
 1. An automated external defibrillator (AED) systemcomprising: an AED operations block for controlling operational aspectsof the AED system, the AED operations block including a pair of pads forattachment to specific locations on a patient, an electrocardiogram(ECG) monitoring circuitry for monitoring patient heartbeat through thepair of pads, shock generating electronics for generating at least oneelectrical shock signal to be applied to the patient through the pair ofpads, a battery for supplying power to the AED operations block, a powermanagement block for managing power consumption by the shock generatingelectronics and monitoring a power status of the battery, a memory forstoring information regarding the AED system, a user-interface (UI)block for providing use instructions and receiving user input, and acontroller for regulating the ECG monitoring circuitry, shock generatingelectronics, and the power management block; and a communications block,also regulated by the controller, for communicating with an externalsystem separate from the AED system.
 2. The AED system of claim 1,wherein the communications block includes at least one of a cellularmodem, a Bluetooth modem, a Wi-Fi modem, a wired connection, and asatellite modem.
 3. The AED system of claim 2, wherein thecommunications block is further configured for communicating with atleast one of a mobile device, an emergency medical services system, abracket configured for housing the AED system therein, a networkedhardware, and cloud.
 4. The AED system of claim 3, wherein thecommunications block is further configured for transmitting at least oneof a location of the AED system and patient information from the AEDsystem to the at least one of the mobile, emergency medical servicessystem, bracket, networked hardware, and cloud.
 5. The AED system ofclaim 3, wherein the networked hardware includes at least one of awearable fitness tracker, a heart monitor, a Bluetooth tracker, a RFIDtracker, a MR tracker, and a smart home device.
 6. The AED system ofclaim 1, wherein the AED operations block further includes at least oneof a wireless charging circuitry and an accelerometer.
 7. A method oftransmitting data from an automated external defibrillator (AED) systemto emergency medical services, the method comprising: at the AED system,gathering at least one of a location of the AED system and patientinformation for a patient; and electronically transmitting the at leastone of the location of the AED system and patient information from theAED system to emergency medical services.
 8. The method of claim 7,wherein patient information includes at least one of cardiac rhythm andvital signs.
 9. The method of claim 7, wherein the AED system includesan AED operations block configured for operating the AED system, andwherein the AED system further includes a communications blockconfigured for receiving information from and transmitting informationto emergency medical services.
 10. The method of claim 9, furthercomprising, upon receipt of patient information, enabling emergencymedical services to remotely control the AED system.
 11. The method ofclaim 10, wherein enabling emergency medical services to remotelycontrol the AED system includes allowing emergency medical services toremotely administer a therapeutic shock to the patient.